A Phase 1 interventional study of Lacosamide and Placebo oral capsule in Alcohol Use Disorder, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by Boston Medical Center · Phase 1, Interventional, and Treatment
This is a double-blind, randomized, placebo-controlled, crossover design trial tested the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this study was to determine whether lacosamide, a novel anticonvulsant that is FDA-approved for treating partial seizures, has effects on alcohol craving and consumption.
The present proposal was intended to answer the call for accelerating drug development by exploring the potential of a novel anticonvulsant, lacosamide, as a candidate medication for the treatment of alcohol use disorder (AUD). This drug, which is approved for the treatment of seizure disorders, has unique pharmacological actions that include enhancement of slow sodium channel inactivation and inhibition of collapsin response mediator protein-2 (CRMP-2). Alcohol consumption in mice that had knockdown of CRMP-2 within the nucleus accumbens was decreased from levels seen in control animals. In rodent studies, lacosamide administration has produced reductions in 'excessive' drinking and has experimentally-induced decreased expression of the CRMP-2 protein. These findings implicate CRMP-2 as playing a role in the regulation of alcohol consumption. None of the FDA-approved AUD medications or medications commonly used off-label to treat AUD target this CRMP-2 pathway, making lacosamide a promising compound for AUD drug development. The aims of this study were to: 1) test the effects of lacosamide on alcohol self-administration and craving, 2) test the effects of 7 days of lacosamide administration on cognitive function, and 3) test the effects of lacosamide on alcohol consumption and craving during a 7-day period of exposure. The effects of 7 days of lacosamide (300mg) or placebo were evaluated in a human laboratory using an alcohol self-administration methodology. In this within-subjects crossover design, heavy drinkers (N=27) were randomized to the order of exposure (lacosamide or placebo) prior to completing two alcohol self-administration trials. Subjects received a priming drink of alcohol and had access to 8 alcoholic drinks over a 2-hour period. The investigators anticipated that subjects would consume less alcohol during an alcohol self-administration trial when receiving lacosamide compared to when they are receiving placebo. Significant lacosamide-induced reductions in the quantity of alcohol self-administered are considered to be an indication that this drug may have value as an AUD medication. This study may provide a rationale for phase II clinical studies testing lacosamide with a treatment-seeking AUD population. These results should also help to spur further pre-clinical investigation into the role play by CRMP-2 in regulating both alcohol consumption and alcohol seeking behaviors.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 66 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject Inclusion Criteria
Subject Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
Drug: Lacosamide
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
Drug: Placebo oral capsule
Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
Also known as: Vimpat
Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
Alcohol Consumption in Alcohol Self-Administration Trials
Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Time frame: 2 hours
Verbal Fluency: Controlled Word Association (COWAT)
The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).
Time frame: 3 minutes
Cognitive Function: Spatial Span Forward
The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
Time frame: 10 minutes
Cognitive Function: Spatial Span Backward
The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
Time frame: 10 minutes
Cognitive Function: Digit Span Forward
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
Time frame: 10 minutes
Cognitive Function: Digit Span Backward
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
Time frame: 10 minutes
Cognitive Function: Digit Span Sequencing
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
Time frame: 10 minutes
Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial
The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.
Time frame: 5 minutes
Alcohol Craving: Visual Analog Scale (VAS) Pretrial
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
Time frame: 1 minute
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
Time frame: 1 minute
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
Time frame: 1 minute
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
Time frame: 1 minute
Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
Time frame: 1 minute
| Milestone | Lacosamide Then Placebo | Placebo Then Lacosamide |
|---|---|---|
| Started | 13 | 14 |
| Completed | 11 | 12 |
| Not completed | 2 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Participation discontinued due to covid-19 research pause | 0 | 1 |
| Milestone | Lacosamide Then Placebo | Placebo Then Lacosamide |
|---|---|---|
| Started | 11 | 12 |
| Completed | 9 | 11 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Failed urine drug screen at time of alcohol trial 1 | 1 | 0 |
| Milestone | Lacosamide Then Placebo | Placebo Then Lacosamide |
|---|---|---|
| Started | 9 | 11 |
| Completed | 8 | 11 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | Lacosamide Then Placebo | Placebo Then Lacosamide |
|---|---|---|
| Started | 8 | 11 |
| Completed | 8 | 11 |
| Not completed | 0 | 0 |
Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
| Standard Drink Units (SDU) | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Consumption in Alcohol Self-Administration Trials | 3.02 ± 3.00 | 2.35 ± 2.31 |
The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Verbal Fluency: Controlled Word Association (COWAT) | 38.19 ± 8.26 | 42.25 ± 9.75 |
The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| correct items | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Cognitive Function: Spatial Span Forward | 8.44 ± 2.53 | 7.75 ± 3.70 |
The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Cognitive Function: Spatial Span Backward | 7.19 ± 2.49 | 7.62 ± 3.14 |
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Cognitive Function: Digit Span Forward | 10.81 ± 1.97 | 10.81 ± 2.10 |
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Cognitive Function: Digit Span Backward | 8.06 ± 1.48 | 7.62 ± 2.16 |
The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Cognitive Function: Digit Span Sequencing | 8.12 ± 2.33 | 7.62 ± 2.36 |
The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.
| scores on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial | 10.19 ± 4.79 | 12.25 ± 5.35 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| scores on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Pretrial | 30.25 ± 31.00 | 31.60 ± 35.65 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| scores on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10 | 26.75 ± 20.07 | 41.87 ± 33.42 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| scores on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20 | 35.31 ± 28.33 | 39.75 ± 34.95 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30 | 35.19 ± 28.85 | 37.81 ± 36.50 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40 | 36.87 ± 26.71 | 36.69 ± 34.50 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30 | 28.00 ± 19.73 | 31.87 ± 30.66 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60 | 24.94 ± 20.78 | 30.37 ± 30.38 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90 | 21.62 ± 21.60 | 27.81 ± 29.52 |
Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120 | 23.62 ± 28.78 | 29.00 ± 32.55 |
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30 | 24.00 ± 7.54 | 23.94 ± 8.65 |
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60 | 24.88 ± 7.49 | 26.25 ± 6.70 |
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90 | 22.94 ± 7.46 | 22.00 ± 4.98 |
The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
| score on a scale | Lacosamide | Placebo Oral Capsule |
|---|---|---|
| Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120 | 24.94 ± 9.45 | 25.44 ± 8.34 |
Collected over Up to 44 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lacosamide | 0/16 (0%) | 0/16 (0%) | 7/16 (43.8%) |
| Placebo | 0/16 (0%) | 0/16 (0%) | 6/16 (37.5%) |
| Event | Lacosamide | Placebo |
|---|---|---|
| Bright yellow urineRenal and urinary disorders | 2/16 | 3/16 |
| IndigestionGastrointestinal disorders | 1/16 | 2/16 |
| DrowsinessGeneral disorders | 1/16 | 1/16 |
| Dry mouthGeneral disorders | 1/16 | 0/16 |
| NauseaGastrointestinal disorders | 1/16 | 0/16 |
| Mosquito bitesSkin and subcutaneous tissue disorders | 1/16 | 0/16 |
| Unpleasant taste in mouthGeneral disorders | 0/16 | 1/16 |
| Mental foginessGeneral disorders | 0/16 | 1/16 |
66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
| Age, Categorical(Participants) | Lacosamide Then Placebo | Placebo Then Lacosamide | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 9 | 16 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Lacosamide Then Placebo | Placebo Then Lacosamide | Total |
|---|---|---|---|
| Mean | 34.5 ± 9.4 | 37.8 ± 8.2 | 36.4 ± 9.2 |
| Sex: Female, Male(Participants) | Lacosamide Then Placebo | Placebo Then Lacosamide | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Lacosamide Then Placebo | Placebo Then Lacosamide | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 6 | 8 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lacosamide Then Placebo | Placebo Then Lacosamide | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 6 | 9 |
| White | 3 | 1 | 4 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Lacosamide Then Placebo | Placebo Then Lacosamide | Total |
|---|---|---|---|
| United States | 7 | 9 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Aug 2020, 28 months.
Results were first posted in Jun 2021, 9 months after primary completion.
Of 63 non-industry phase 1 interventional studies under Alcoholism, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's 28 months is below that.
Counting every sponsor, half of 75 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lacosamide