Trial · NCT01076283
A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
NCT01076283, Phase 2, Completed, Brown University; results first posted 2013-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking. Trials, record NCT01076283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01076283
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
- NCT number
- NCT01076283
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Brown University
- Conditions
- Alcoholism
- Interventions
- Baclofen, Cyproheptadine
- First posted
- 2010-02-26
- Last updated
- 2013-10-17
- Results first posted
- 2013-10-17
- Limitations and caveats
- Very small sample. This pilot trial was primarily aimed to determine a power analysis for future larger trials.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alcohol Urge | approximately 8 days after drug administration | Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink \[as measured by the Alcohol Urge Questionnaire (AUQ)\] during the Cue Reactivity. The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome). |
| Primary | Alcohol Drinking | approximately 8 days after drug administration | Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration (ASA). Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour "free-choice" phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as "standard drinking unit", where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Alcohol Urge | approximately 8 days after drug administration | units on a scale | MEAN | |
| PRIMARY | Alcohol Drinking | approximately 8 days after drug administration | standard drinking units | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Alcohol Urge | Baclofen | 22.5 | Standard Deviation 11.4 | units on a scale | |
| Alcohol Urge | Cyproheptadine | 19.4 | Standard Deviation 19.6 | units on a scale | |
| Alcohol Drinking | Baclofen | 0.17 | Standard Deviation 0.41 | standard drinking units | |
| Alcohol Drinking | Cyproheptadine | 1.43 | Standard Deviation 2.30 | standard drinking units |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Baclofen | 7 | |
| Overall Study | STARTED | Cyproheptadine | 7 | |
| Overall Study | COMPLETED | Baclofen | 6 | |
| Overall Study | COMPLETED | Cyproheptadine | 7 | |
| Overall Study | NOT COMPLETED | Baclofen | 1 | |
| Overall Study | NOT COMPLETED | Cyproheptadine | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | sleepness | Nervous system disorders | Baclofen | 2 | 7 | |
| other | sleepness | Nervous system disorders | Cyproheptadine | 1 | 7 | |
| other | increased urination | Renal and urinary disorders | Baclofen | 1 | 7 | |
| other | increased urination | Renal and urinary disorders | Cyproheptadine | 0 | 7 | |
| other | cramps | Musculoskeletal and connective tissue disorders | Baclofen | 1 | 7 | 2 |
| other | cramps | Musculoskeletal and connective tissue disorders | Cyproheptadine | 0 | 7 | |
| other | constipation | Gastrointestinal disorders | Baclofen | 0 | 7 | |
| other | constipation | Gastrointestinal disorders | Cyproheptadine | 1 | 7 | |
| other | yellow urine | Renal and urinary disorders | Baclofen | 0 | 7 | |
| other | yellow urine | Renal and urinary disorders | Cyproheptadine | 1 | 7 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baclofen | ||
| Total, all-cause mortality | Cyproheptadine | ||
| Total, other adverse events | Baclofen | 6 | 7 |
| Total, other adverse events | Cyproheptadine | 3 | 7 |
| Total, serious adverse events | Baclofen | 0 | 7 |
| Total, serious adverse events | Cyproheptadine | 0 | 7 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Baclofen vs Cyproheptadine: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Food Cue Reactivity Task | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01076283
GET https://conductscience.org/api/trials/v1/NCT01076283/events?page=2