Trial · NCT01751386
Baclofen for Treating Anxiety and Alcoholism
NCT01751386, Phase 2, Completed, National Institute on Alcohol Abuse and Alcoholism (NIAAA); results first posted 2017-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Baclofen for Treating Anxiety and Alcoholism. Trials, record NCT01751386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Baclofen for Treating Anxiety and Alcoholism
- NCT number
- NCT01751386
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Conditions
- Alcoholism, Alcohol Dependence, Alcohol Drinking Related Problems, Alcohol Drinking, Anxiety Disorder
- Interventions
- Baclofen, Placebo
- First posted
- 2012-12-18
- Last updated
- 2017-09-18
- Results first posted
- 2017-08-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session | 2 hours | Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session | 2 hours | The analysis included all subjects who took the medication (either baclofen or placebo) and finished the alcohol laboratory session | mini-drinks | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session | Baclofen | 4.11 | Standard Error 0.66 | mini-drinks | |
| Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session | Placebo | 4.5 | Standard Error 0.72 | mini-drinks |
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 | 20 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | COMPLETED | Baclofen | 18 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Baclofen | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events32
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 | Abdominal distension | Gastrointestinal disorders | Baclofen | 0 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 2 | 19 | |
| other | Constipation | Gastrointestinal disorders | Baclofen | 1 | 20 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 19 | |
| other | Decreased appetite | General disorders | Baclofen | 0 | 20 | |
| other | Decreased appetite | General disorders | Placebo | 2 | 19 | |
| other | Fatigue | General disorders | Baclofen | 0 | 20 | |
| other | Fatigue | General disorders | Placebo | 2 | 19 | |
| other | Increased appetite | Metabolism and nutrition disorders | Baclofen | 1 | 20 | |
| other | Increased appetite | Metabolism and nutrition disorders | Placebo | 0 | 19 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baclofen | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, other adverse events | Baclofen | 9 | 20 |
| Total, other adverse events | Placebo | 7 | 19 |
| Total, serious adverse events | Baclofen | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers8
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Baclofen vs Placebo: deaths from any cause | Trial comparisons |
| Baclofen vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01751386
GET https://conductscience.org/api/trials/v1/NCT01751386/events?page=2