A Phase 2 interventional study of Acamprosate and Naltrexone in Alcoholism, sponsored by The Scripps Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by The Scripps Research Institute · Phase 2, Interventional, and Other
The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.
This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 68 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →The Scripps Research Institute is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acamprosate
Drug: Acamprosate
Naltrexone
Drug: Naltrexone
Drug: Placebo
Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
Also known as: Campral
50mg capsule, Once daily, 1 week duration
Also known as: ReVia
Matched placebo capsule, 1 week duration
Also known as: Sugar pill
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period
The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.
Time frame: 1 week
Change From Baseline in Standard Drinks Per Week at 1 Week
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.
Time frame: 1 week
Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1
The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.
Time frame: 1 week
Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1
The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.
Time frame: 1 week
Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1
The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.
Time frame: 2 weeks
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, California from 04/17/2008-12/10/2009. Sixty eight subjects were enrolled, and sixty two subjects completed the study.
| Milestone | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) |
|---|---|---|---|
| Started | 22 | 27 | 19 |
| Completed | 20 | 25 | 17 |
| Not completed | 2 | 2 | 2 |
The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.
| units on a scale | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) |
|---|---|---|---|
| Strength | 2.12 ± 3.10 | 3.40 ± 3.87 | 5.86 ± 4.79 |
| Intent | 1.65 ± 1.56 | 2.99 ± 3.67 | 4.22 ± 4.34 |
| Impulse | 1.17 ± 1.94 | 1.69 ± 2.78 | 4.31 ± 4.82 |
| Relief | 0.07 ± 1.67 | 2.01 ± 3.56 | 3.57 ± 4.14 |
| Total | 5.00 ± 6.24 | 10.09 ± 12.12 | 17.96 ± 15.83 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.
| drinks/week | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) |
|---|---|---|---|
| Drinks/week Baseline | 44.90 ± 61.89 | 47.02 ± 24.08 | 48.87 ± 58.53 |
| Drinks/week Week 1 | 24.37 ± 22.81 | 25.79 ± 14.32 | 21.51 ± 18.88 |
| Drinks/week Change | -20.53 ± 60.68 | -21.23 ± 23.93 | -27.35 ± 44.84 |
The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.
| units on a scale | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) |
|---|---|---|---|
| BDI-II Total Baseline | 4.40 ± 5.14 | 4.04 ± 4.33 | 3.53 ± 4.74 |
| BDI-II Total Week 1 | 4.75 ± 4.81 | 3.84 ± 4.02 | 4.94 ± 5.70 |
| BDI-II Total Change | 0.35 ± 4.16 | -0.20 ± 2.84 | 1.41 ± 4.30 |
The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.
| units on a scale | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) |
|---|---|---|---|
| PSQI Total Baseline | 4.50 ± 3.14 | 4.74 ± 3.62 | 4.25 ± 2.82 |
| PSQI Total Week 1 | 4.69 ± 3.88 | 4.57 ± 3.55 | 4.38 ± 3.67 |
| PSQI Total Change | 0.19 ± 3.78 | -0.17 ± 2.08 | 0.13 ± 2.68 |
The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.
| units on a scale | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) |
|---|---|---|---|
| ACQ-SF Total Screening | 3.80 ± 1.38 | 3.81 ± 1.55 | 3.99 ± 1.34 |
| ACQ-SF Total Week 1 | 3.36 ± 1.28 | 3.69 ± 1.26 | 3.51 ± 0.98 |
| ACQ-SF Total Change | -0.44 ± 1.02 | -0.12 ± 1.56 | -0.48 ± 1.12 |
Collected over Adverse event data was collected at all four study visits, an average duration of 4 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acamprosate | — | 0/20 (0%) | 8/20 (40%) |
| Naltrexone | — | 0/25 (0%) | 9/25 (36%) |
| Placebo | — | 0/17 (0%) | 3/17 (17.6%) |
| Event | Acamprosate | Naltrexone | Placebo |
|---|---|---|---|
| FatigueGeneral disorders | 3/20 | 0/25 | 0/17 |
| NauseaGastrointestinal disorders | 1/20 | 3/25 | 0/17 |
| NasopharyngitisInfections and infestations | 2/20 | 2/25 | 1/17 |
| DepressionPsychiatric disorders | 2/20 | 0/25 | 0/17 |
| DiaherreaGastrointestinal disorders | 2/20 | 0/25 | 0/17 |
| HeadacheNervous system disorders | 1/20 | 2/25 | 1/17 |
| Stomach painGastrointestinal disorders | 0/20 | 2/25 | 0/17 |
| DizzinessNervous system disorders | 1/20 | 2/25 | 0/17 |
| Decreased libidoPsychiatric disorders | 0/20 | 0/25 | 1/17 |
| LacerationInjury, poisoning and procedural complications | 0/20 | 0/25 | 1/17 |
| Age, Continuous(years) | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) | Total |
|---|---|---|---|---|
| Mean | 35.73 ± 10.10 | 36.37 ± 12.45 | 42.84 ± 10.37 | 37.97 ± 11.42 |
| Sex: Female, Male(Participants) | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) | Total |
|---|---|---|---|---|
| Female | 10 | 6 | 6 | 22 |
| Male | 12 | 21 | 13 | 46 |
| Region of Enrollment(participants) | Campral (Acamprosate) | ReVia (Naltrexone) | Sugar Pill (Placebo) | Total |
|---|---|---|---|---|
| United States | 22 | 27 | 19 | 68 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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