Trial · NCT02252536
HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
NCT02252536, Phase 2, Completed, National Institute on Alcohol Abuse and Alcoholism (NIAAA); results first posted 2018-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder. Trials, record NCT02252536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02252536
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
- NCT number
- NCT02252536
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 346 participants, actual
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Conditions
- Alcohol Use Disorder
- Interventions
- gabapentin enacarbil, Placebo
- First posted
- 2014-09-30
- Last updated
- 2018-11-14
- Results first posted
- 2018-09-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With no Heavy Drinking Days (PSNHDD) | Weeks 22-25 | The primary objective of the study is to compare the efficacy of HORIZANT (gabapentin enacarbil) Extended-Release Tablets 600 mg twice daily (BID) with matched placebo on the primary alcohol consumption outcome endpoint, percentage of subjects with no heavy drinking days (PSNHDD) during the last 4 weeks of treatment, among patients with Alcohol Use Disorder (AUD). |
| Secondary | Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) | Weeks 22-25 | Timeline Follow-back drinking data is used to calculate the % of subjects that report not drinking alcohol during weeks 22-25 |
| Secondary | Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level | Weeks 22-25 | Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g |
| Secondary | Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels | Weeks 22-25 | Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g |
| Secondary | Percentage of Days Abstinent Per Week | Weeks 22-25 | Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week. |
| Secondary | Percentage of Heavy Drinking Days Per Week | Weeks 22-25 | Timeline Follow Back data used to calculate the % of heavy drinking days per week. Heavy drinking is 4+ drinks per day for females and 5+ drinks per day for males |
| Secondary | Weekly Mean Number of Drinks Per Week | Weeks 22-25 | Timeline Follow Back data used to calculate the weekly mean number of drinks per week |
| Secondary | Weekly Mean Drinks Per Drinking Day | Weeks 22-25 | Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day |
| Secondary | Cigarettes Per Week Among Smokers | Weeks 22-25 | A quantity frequency interview of three questions to assess cigarette smoking behavior and other tobacco/nicotine containing products use during the study: 1) "Over the past week, on how many days did you smoke cigarettes?", 2) "On the days you smoked during the past week, how many cigarettes did you smoke on average?", and 3) "Have you used any other tobacco or nicotine containing products besides cigarettes in the past week (e.g., cigars, cigarellos, pipes, bidis, or smokeless tobacco such as pan, chewing tobacco, or snuff, or nicotine replacement therapies such as patch or gum)?". |
| Secondary | Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)] | Weeks 24 and 26 | The ACQ-SR-R contains 12-items adapted from the 47-item ACQ-NOW developed by Singleton et al (1994) to assess craving for alcohol among alcohol users in the current context (right now). Each item has a 1 to 7 raw score (from strongly disagree to strongly agree). Items 3, 8, and 11 are reverse keyed. A general craving index is derived by summing all items and dividing by 12. Minimum score is 1 and maximum score is 7. Higher scores are indicative of higher craving. Mixed effects models as stated in Section 9.4.3 of the SAP will be generated for the total score and for the 4 subscales. Covariates for these models will be identified |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With no Heavy Drinking Days (PSNHDD) | Weeks 22-25 | percentage of subjects with NHDD | NUMBER | |
| SECONDARY | Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) | Weeks 22-25 | no imputation was performed so the number analyzed is reduced | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level | Weeks 22-25 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels | Weeks 22-25 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Days Abstinent Per Week | Weeks 22-25 | percentage of days | LEAST_SQUARES_MEAN | |
| SECONDARY | Percentage of Heavy Drinking Days Per Week | Weeks 22-25 | percentage of days | LEAST_SQUARES_MEAN | |
| SECONDARY | Weekly Mean Number of Drinks Per Week | Weeks 22-25 | drinks per week | LEAST_SQUARES_MEAN | |
| SECONDARY | Weekly Mean Drinks Per Drinking Day | Weeks 22-25 | drinks per drinking day | LEAST_SQUARES_MEAN | |
| SECONDARY | Cigarettes Per Week Among Smokers | Weeks 22-25 | cigarettes per week | LEAST_SQUARES_MEAN | |
| SECONDARY | Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)] | Weeks 24 and 26 | scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With no Heavy Drinking Days (PSNHDD) | Sugar Pill | 17.3 | percentage of subjects with NHDD | ||
| Percentage of Subjects With no Heavy Drinking Days (PSNHDD) | Gabapentin Enacarbil | 24.1 | percentage of subjects with NHDD | ||
| Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) | Sugar Pill | 16 | Participants | ||
| Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) | Gabapentin Enacarbil | 17 | Participants | ||
| Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level | Sugar Pill | 107 | Participants | ||
| Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level | Gabapentin Enacarbil | 115 | Participants | ||
| Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels | Sugar Pill | 69 | Participants | ||
| Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels | Gabapentin Enacarbil | 80 | Participants | ||
| Percentage of Days Abstinent Per Week | Sugar Pill | 49 | Standard Error 3.9 | percentage of days | |
| Percentage of Days Abstinent Per Week | Gabapentin Enacarbil | 49.3 | Standard Error 3.9 | percentage of days |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sugar Pill | 173 | |
| Overall Study | STARTED | Gabapentin Enacarbil | 173 | |
| Overall Study | COMPLETED | Sugar Pill | 168 | |
| Overall Study | COMPLETED | Gabapentin Enacarbil | 170 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 5 | |
| Overall Study | NOT COMPLETED | Gabapentin Enacarbil | 3 |
Source ClinicalTrials.gov
Adverse events82
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 | Diarrhea | Gastrointestinal disorders | Sugar Pill | 10 | 168 | |
| other | Diarrhea | Gastrointestinal disorders | Gabapentin Enacarbil | 11 | 170 | |
| other | Nausea | Gastrointestinal disorders | Sugar Pill | 23 | 168 | |
| other | Nausea | Gastrointestinal disorders | Gabapentin Enacarbil | 17 | 170 | |
| other | Blood Pressure diastolic increased | Investigations | Sugar Pill | 42 | 168 | |
| other | Blood Pressure diastolic increased | Investigations | Gabapentin Enacarbil | 43 | 170 | |
| other | Headache | Nervous system disorders | Sugar Pill | 47 | 168 | |
| other | Headache | Nervous system disorders | Gabapentin Enacarbil | 38 | 170 | |
| other | Fatigue | General disorders | Sugar Pill | 26 | 168 | |
| other | Fatigue | General disorders | Gabapentin Enacarbil | 44 | 170 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sugar Pill | 0 | 168 |
| Total, all-cause mortality | Gabapentin Enacarbil | 1 | 170 |
| Total, other adverse events | Sugar Pill | 155 | 168 |
| Total, other adverse events | Gabapentin Enacarbil | 157 | 170 |
| Total, serious adverse events | Sugar Pill | 6 | 168 |
| Total, serious adverse events | Gabapentin Enacarbil | 8 | 170 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sugar Pill vs Gabapentin Enacarbil: Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level | Trial comparisons |
| Sugar Pill vs Gabapentin Enacarbil: Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels | Trial comparisons |
| Sugar Pill vs Gabapentin Enacarbil: deaths from any cause | Trial comparisons |
| Sugar Pill vs Gabapentin Enacarbil: Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) | Trial comparisons |
| Sugar Pill vs Gabapentin Enacarbil: 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.
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