Trial · NCT02349477
Gabapentin for Alcohol Relapse Prevention
NCT02349477, Phase 2, Completed, Medical University of South Carolina; results first posted 2019-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gabapentin for Alcohol Relapse Prevention. Trials, record NCT02349477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02349477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gabapentin for Alcohol Relapse Prevention
- NCT number
- NCT02349477
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Interventions
- Gabapentin, Placebo
- First posted
- 2015-01-29
- Last updated
- 2019-11-04
- Results first posted
- 2019-11-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Subjects With no Heavy Drinking Days (PSNHDD) | 4 months | The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT. |
| Secondary | Percent of Subjects With no Drinking Days (PSNDD) | 4 months | The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT. |
| Other | Number of Participants With No Drinking Days by AWS Score and Medication | 4 months | This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Subjects With no Heavy Drinking Days (PSNHDD) | 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Subjects With no Drinking Days (PSNDD) | 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With No Drinking Days by AWS Score and Medication | 4 months | The data for this analysis were split into two subgroups, based on the median split of AWS. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Subjects With no Heavy Drinking Days (PSNHDD) | Gabapentin | 12 | Participants | ||
| Percent of Subjects With no Heavy Drinking Days (PSNHDD) | Placebo | 4 | Participants | ||
| Percent of Subjects With no Drinking Days (PSNDD) | Gabapentin | 8 | Participants | ||
| Percent of Subjects With no Drinking Days (PSNDD) | Placebo | 2 | Participants | ||
| Number of Participants With No Drinking Days by AWS Score and Medication | Low AWS/Gabapentin | 2 | Participants | ||
| Number of Participants With No Drinking Days by AWS Score and Medication | Low AWS/Placebo | 3 | Participants | ||
| Number of Participants With No Drinking Days by AWS Score and Medication | High AWS/Gabapentin | 10 | Participants | ||
| Number of Participants With No Drinking Days by AWS Score and Medication | High AWS/Placebo | 1 | Participants |
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 | Gabapentin | 44 | |
| Overall Study | STARTED | Placebo | 46 | |
| Overall Study | COMPLETED | Gabapentin | 31 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | Gabapentin | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events36
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 Pain | Gastrointestinal disorders | Gabapentin | 10 | 44 | 12 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 11 | 46 | 16 |
| other | Decreased Appetite | General disorders | Gabapentin | 12 | 44 | 18 |
| other | Decreased Appetite | General disorders | Placebo | 11 | 46 | 13 |
| other | Decreased Libido | General disorders | Gabapentin | 12 | 44 | 24 |
| other | Decreased Libido | General disorders | Placebo | 5 | 46 | 11 |
| other | Depression | Psychiatric disorders | Gabapentin | 24 | 44 | 80 |
| other | Depression | Psychiatric disorders | Placebo | 22 | 46 | 60 |
| other | Diarrhea | Gastrointestinal disorders | Gabapentin | 23 | 44 | 62 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 23 | 46 | 42 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | 0 | 44 |
| Total, all-cause mortality | Placebo | 0 | 46 |
| Total, other adverse events | Gabapentin | 44 | 44 |
| Total, other adverse events | Placebo | 44 | 46 |
| Total, serious adverse events | Gabapentin | 0 | 44 |
| Total, serious adverse events | Placebo | 0 | 46 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gabapentin vs Placebo: Percent of Subjects With no Drinking Days (PSNDD) | Trial comparisons |
| Gabapentin vs Placebo: Percent of Subjects With no Heavy Drinking Days (PSNHDD) | Trial comparisons |
| Gabapentin vs Placebo: deaths from any cause | Trial comparisons |
| Gabapentin 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/NCT02349477
GET https://conductscience.org/api/trials/v1/NCT02349477/events?page=2