A Phase 1 interventional study of Alcohol and Placebos in Alcohol Use Disorder, sponsored by Craig Rush. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Craig Rush · Phase 1, Interventional, and Basic science
This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.
Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020.
For both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study.
Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 19 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Craig Rush is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Subjects received oral placebo capsules one time daily.
Drug: Alcohol · Drug: Placebos · Drug: Methylphenidate
Subjects received 60 mg of oral duloxetine one time daily.
Drug: Duloxetine (60 MG)
Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.
Drug: Duloxetine (30 MG)
In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Subjects will receive oral placebo capsules.
Subjects will receive 60-mg of oral duloxetine capsules.
Subjects will receive methylphenidate capsules.
Subjects will receive 30-mg of oral duloxetine capsules.
Reinforcing Effects (Pre-Alcohol Dose Consumption)
The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Reinforcing Effects (Post-Alcohol Dose Consumption)
The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Breath Alcohol Level
Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Systolic Blood Pressure
Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Diastolic Blood Pressure
Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
Heart Rate
Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Milestone | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Started | 11 | 2 | 6 |
| 0 mg methylphenidate | 11 | 2 | 6 |
| 20 mg methylphenidate | 10 | 2 | 6 |
| 40 mg methylphenidate | 10 | 2 | 6 |
| 60 mg methylphenidate | 9 | 2 | 6 |
| Completed | 9 | 2 | 6 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: One subject left due to personal reasons unrelated to study-procedures | 1 | 0 | 0 |
The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
| Units on a Theoretical Scale | Placebo | Duloxetine 30 mg | Duloxetine (60 MG) |
|---|---|---|---|
| Methylphenidate (0 mg) | 0.005 (0.0043 to 0.0057) | .01 (0.0078 to 0.012) | 0.007 (0.005 to 0.008) |
| Methylphenidate (20 mg) | 0.005 (0.0041 to 0.0058) | .02 (0.014 to 0.020) | 0.007 (0.006 to 0.009) |
| Methylphenidate (40 mg) | 0.005 (0.0041 to 0.0057) | 0.014 (0.012 to 0.018) | 0.007 (0.006 to 0.008) |
| Methylphenidate (60 mg) | 0.005 (0.0041 to 0.0057) | .02 (0.012 to 0.020) | 0.008 (0.006 to 0.009) |
The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.
| Units on a Theoretical Scale | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Methylphenidate (0 mg) | 0.004 (0.0038 to 0.0052) | .01 (0.0075 to 0.010) | 0.006 (0.005 to 0.008) |
| Methylphenidate (20 mg) | 0.005 (0.0041 to 0.0054) | .01 (0.010 to 0.013) | 0.007 (0.005 to 0.008) |
| Methylphenidate (40 mg) | 0.005 (0.0039 to 0.0053) | .014 (0.011 to 0.017) | 0.006 (0.005 to 0.008) |
| Methylphenidate (60 mg) | 0.005 (0.0044 to 0.0056) | .01 (0.010 to 0.016) | 0.009 (0.007 to 0.011) |
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
| units on a scale | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Feel Drink | 15.89 ± 15.45 | 4.50 ± 2.12 | 22.00 ± 17.34 |
| Feel High | 0.11 ± 0.33 | 1.00 ± 1.41 | 2.00 ± 3.95 |
| Like Drink | 12.33 ± 16.08 | 4.50 ± 0.71 | 25.33 ± 20.30 |
| Want Drink | 17.22 ± 17.48 | 7.50 ± 0.71 | 23.50 ± 20.42 |
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
| units on a scale | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Feel Drink | 17.44 ± 11.68 | 10.50 ± 6.36 | 28.50 ± 20.11 |
| Feel High | 0.22 ± 0.67 | 1.50 ± 2.12 | 1.83 ± 4.02 |
| Like Drink | 16.78 ± 23.55 | 9.50 ± 6.36 | 27.33 ± 22.14 |
| Want Drink | 19.22 ± 19.57 | 15.50 ± 4.95 | 32.33 ± 24.66 |
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
| units on a scale | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Feel Drink | 10.67 ± 8.79 | 7.50 ± 2.12 | 20.17 ± 11.50 |
| Feel High | 0.11 ± 0.33 | 1.00 ± 1.41 | 2.50 ± 4.18 |
| Like Drink | 16.89 ± 21.97 | 10.00 ± 1.41 | 24.00 ± 18.28 |
| Want Drink | 11.11 ± 12.58 | 15.00 ± 0.00 | 26.00 ± 27.31 |
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
| units on a scale | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Feel Drink | 12.67 ± 10.97 | 5.50 ± 2.12 | 17.17 ± 13.83 |
| Feel High | 0.11 ± 0.33 | 1.00 ± 1.41 | 1.17 ± 2.40 |
| Like Drink | 10.78 ± 12.77 | 8.00 ± 0.00 | 20.50 ± 21.14 |
| Want Drink | 8.44 ± 13.60 | 15.00 ± 1.41 | 15.17 ± 11.48 |
Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.
| g/dl | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Methylphenidate (0 mg) | 0.026 ± 0.014 | 0.031 ± 0.006 | 0.029 ± 0.013 |
| Methylphenidate (20 mg) | 0.024 ± 0.006 | 0.031 ± 0.004 | 0.042 ± 0.030 |
| Methylphenidate (40 mg) | 0.024 ± 0.008 | 0.041 ± 0.006 | 0.034 ± 0.021 |
| Methylphenidate (60 mg) | 0.026 ± 0.007 | 0.023 ± 0.005 | 0.037 ± 0.015 |
Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
| Millimeters of mercury | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Methylphenidate (0 mg) | 125.00 ± 13.65 | 129.00 ± 19.80 | 124.00 ± 8.90 |
| Methylphenidate (20 mg) | 126.67 ± 12.35 | 140.00 ± 9.90 | 121.67 ± 6.53 |
| Methylphenidate (40 mg) | 123.33 ± 10.39 | 130.00 ± 18.38 | 124.33 ± 8.73 |
| Methylphenidate (60 mg) | 125.44 ± 12.17 | 131.50 ± 9.19 | 127.50 ± 11.98 |
Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
| Millimeter of mercury | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Methylphenidate (0 mg) | 73.56 ± 10.17 | 82.00 ± 12.73 | 77.67 ± 6.71 |
| Methylphenidate (20 mg) | 74.00 ± 9.49 | 88.50 ± 6.36 | 77.00 ± 8.51 |
| Methylphenidate (40 mg) | 74.22 ± 7.08 | 85.50 ± 9.19 | 80.33 ± 5.09 |
| Methylphenidate (60 mg) | 74.00 ± 8.89 | 82.00 ± 8.49 | 80.50 ± 9.14 |
Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
| Beats per minute | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| Methylphenidate (0 mg) | 75.89 ± 11.47 | 66.50 ± 4.95 | 75.83 ± 11.41 |
| Methylphenidate (20 mg) | 83.44 ± 12.63 | 80.50 ± 3.54 | 84.83 ± 11.43 |
| Methylphenidate (40 mg) | 81.67 ± 7.48 | 73.50 ± 2.12 | 88.83 ± 13.01 |
| Methylphenidate (60 mg) | 83.89 ± 13.04 | 80.50 ± 2.12 | 98.50 ± 21.72 |
Collected over Four weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/11 (0%) | 0/11 (0%) | 11/11 (100%) |
| Duloxetine (30 MG) | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Duloxetine (60 MG) | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) |
|---|---|---|---|
| AnxietyNervous system disorders | 3/11 | 2/2 | 3/6 |
| Body AchesMusculoskeletal and connective tissue disorders | 2/11 | 2/2 | 0/6 |
| DizzinessNervous system disorders | 0/11 | 2/2 | 1/6 |
| DiarrheaGastrointestinal disorders | 5/11 | 2/2 | 2/6 |
| HeadacheGeneral disorders | 4/11 | 2/2 | 3/6 |
| Muscle AchesMusculoskeletal and connective tissue disorders | 1/11 | 2/2 | 0/6 |
| NauseaGeneral disorders | 2/11 | 2/2 | 3/6 |
| Sleepiness/DowsinessGeneral disorders | 2/11 | 2/2 | 2/6 |
| Sore ThroatGeneral disorders | 2/11 | 2/2 | 1/6 |
| RestlessnessGeneral disorders | 3/11 | 2/2 | 3/6 |
| Age, Categorical(Participants) | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 2 | 6 | 19 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) | Total |
|---|---|---|---|---|
| Mean | 31.27 ± 9.00 | 32.50 ± 13.44 | 30.25 ± 10.66 | 30.48 ± 9.46 |
| Sex: Female, Male(Participants) | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) | Total |
|---|---|---|---|---|
| Female | 5 | 0 | 3 | 8 |
| Male | 6 | 2 | 3 | 11 |
| Race (NIH/OMB)(Participants) | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 9 | 2 | 6 | 17 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Duloxetine (30 MG) | Duloxetine (60 MG) | Total |
|---|---|---|---|---|
| United States | 11 | 2 | 6 | 19 |
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Studies of the drug tested here: Duloxetine
Craig Rush