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HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252536
Recruitment Status : Completed
First Posted : September 30, 2014
Results First Posted : September 21, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Arbor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Use Disorder
Interventions Drug: gabapentin enacarbil
Drug: Placebo
Enrollment 346
Recruitment Details The study was a Phase 2, randomized, double-blind, placebo controlled, parallel-group 26-week treatment clinical trial. Candidates responded by telephone to advertisements at 10 academic sites in the US between June 2015 and February 2017.
Pre-assignment Details  
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Period Title: Overall Study
Started 173 173
Completed 168 170
Not Completed 5 3
Reason Not Completed
Lost to Follow-up             5             3
Arm/Group Title Sugar Pill Gabapentin Enacarbil Total
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day

 Total of all reporting groups
Overall Number of Baseline Participants 168 170 338
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 170 participants 338 participants
49.4  (11.4) 50.7  (10.3) 50.1  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 170 participants 338 participants
Female
67
  39.9%
48
  28.2%
115
  34.0%
Male
101
  60.1%
122
  71.8%
223
  66.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 170 participants 338 participants
Hispanic or Latino
18
  10.7%
14
   8.2%
32
   9.5%
Not Hispanic or Latino
146
  86.9%
150
  88.2%
296
  87.6%
Unknown or Not Reported
4
   2.4%
6
   3.5%
10
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 170 participants 338 participants
American Indian or Alaska Native
2
   1.2%
1
   0.6%
3
   0.9%
Asian
0
   0.0%
3
   1.8%
3
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
28
  16.7%
35
  20.6%
63
  18.6%
White
126
  75.0%
117
  68.8%
243
  71.9%
More than one race
10
   6.0%
9
   5.3%
19
   5.6%
Unknown or Not Reported
2
   1.2%
5
   2.9%
7
   2.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 168 participants 170 participants 338 participants
168
 100.0%
170
 100.0%
338
 100.0%
1.Primary Outcome
Title Percentage of Subjects With no Heavy Drinking Days (PSNHDD)
Hide Description 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).
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Measure Type: Number
Unit of Measure: percentage of subjects with NHDD
17.3 24.1
2.Secondary Outcome
Title Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint)
Hide Description Timeline Follow-back drinking data is used to calculate the % of subjects that report not drinking alcohol during weeks 22-25
Time Frame Weeks 22-25
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no imputation was performed so the number analyzed is reduced
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 136 146
Measure Type: Count of Participants
Unit of Measure: Participants
16
  11.8%
17
  11.6%
3.Secondary Outcome
Title Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level
Hide Description

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
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 134 146
Measure Type: Count of Participants
Unit of Measure: Participants
107
  79.9%
115
  78.8%
4.Secondary Outcome
Title Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels
Hide Description

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
Time Frame Weeks 22-25
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 134 146
Measure Type: Count of Participants
Unit of Measure: Participants
69
  51.5%
80
  54.8%
5.Secondary Outcome
Title Percentage of Days Abstinent Per Week
Hide Description Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week.
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: percentage of days
49  (3.9) 49.3  (3.9)
6.Secondary Outcome
Title Percentage of Heavy Drinking Days Per Week
Hide Description 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
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: percentage of days
46.5  (4.2) 43.1  (4.1)
7.Secondary Outcome
Title Weekly Mean Number of Drinks Per Week
Hide Description Timeline Follow Back data used to calculate the weekly mean number of drinks per week
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: drinks per week
21.4  (2.4) 23.1  (2.3)
8.Secondary Outcome
Title Weekly Mean Drinks Per Drinking Day
Hide Description Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: drinks per drinking day
3.9  (0.4) 4.1  (0.4)
9.Secondary Outcome
Title Cigarettes Per Week Among Smokers
Hide Description 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)?".
Time Frame Weeks 22-25
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: cigarettes per week
61.4  (8.3) 71  (8.3)
10.Secondary Outcome
Title Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)]
Hide Description

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
Time Frame Weeks 24 and 26
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.5  (0.1) 2.5  (0.1)
11.Secondary Outcome
Title Alcohol Related Consequences (ImBIBe) Score
Hide Description

ImBIBe is a 15-item questionnaire in which the subject responds on a 5-point scale (0-4) responses to questions on the consequences of alcohol use. This scale was adapted from the Drinker Inventory of Consequences questionnaire based on FDA recommendations on patient reported outcomes (Miller & Tonigen-1995). The potential range is 0-60. A higher score indicates a worse outcome. The questions are added together. A question that is missing is imputed with the average value of all other questions in the questionnaire.The total score is the sum of the individual item scores.

Mixed effects models as stated in Section 9.4.3 will be generated for the total score. Covariates for these models will be identified
Time Frame Weeks 24 and 26
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: total score
8.3  (0.7) 9.6  (0.7)
12.Secondary Outcome
Title Pittsburgh Sleep Quality Index (PSQI) Score
Hide Description The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); >6 indicative of "poor" sleep quality.
Time Frame Week 26
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: score
4.4  (0.2) 4.9  (0.2)
13.Secondary Outcome
Title Beck Anxiety Inventory (BAI) Score
Hide Description The BAI consists of 21 questions about how the subject has been feeling in the last week, expressed as common symptoms of anxiety (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). This inventory was designed to minimize the overlap with depression scales (Beck et al-1988).The BAI has a maximum score of 63. The standardized cutoffs for anxiety severity are: 0-7: minimal level of anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety
Time Frame Week 26
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: score
3.3  (0.5) 4.6  (0.4)
14.Secondary Outcome
Title Beck Depression Inventory - II
Hide Description

The BDI-II is a 21-item multiple choice questionnaire that is used for measuring the severity of depression (Beck et al-1966). Each item is scored on a scale value of 0 to 3. The standardized cutoffs for depression severity are:

0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Time Frame Week 26
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[Not Specified]
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Overall Number of Participants Analyzed 168 170
Least Squares Mean (Standard Error)
Unit of Measure: score
5.2  (0.5) 6.5  (0.5)
Time Frame AEs were assessed from Week 1 - Week 29.
Adverse Event Reporting Description General symptoms were collected via an open ended question: "How have you been feeling since your last visit or the last time we spoke?"
 
Arm/Group Title Sugar Pill Gabapentin Enacarbil
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Matching placebo, sugar pill

Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

600 mg Gabapentin Enacarbil (Horizant)

gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
All-Cause Mortality
Sugar Pill Gabapentin Enacarbil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/168 (0.00%)      1/170 (0.59%)    
Hide Serious Adverse Events
Sugar Pill Gabapentin Enacarbil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/168 (3.57%)      8/170 (4.71%)    
Cardiac disorders     
Bradycardia during colonoscopy † 1  1/168 (0.60%)  1 0/170 (0.00%)  0
Gastrointestinal disorders     
Stomach Ulcer † 1  1/168 (0.60%)  1 0/170 (0.00%)  0
Infections and infestations     
pneumonia † 1  0/168 (0.00%)  0 2/170 (1.18%)  3
Head Laceration complicated by orbital fracture † 1  0/168 (0.00%)  0 1/170 (0.59%)  1
Injury, poisoning and procedural complications     
Orbital Fracture † 1  0/168 (0.00%)  0 1/170 (0.59%)  1
Acute Intoxication † 1  0/168 (0.00%)  0 1/170 (0.59%)  1
Comminuted impacted fracture of the right humeral head † 1  1/168 (0.60%)  1 0/170 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain † 1  0/168 (0.00%)  0 1/170 (0.59%)  1
Nervous system disorders     
Alcohol Withdrawal † 1  0/168 (0.00%)  0 3/170 (1.76%)  3
migraine with left eye drooping † 1  0/168 (0.00%)  0 1/170 (0.59%)  1
Psychiatric disorders     
Suicidality † 1  1/168 (0.60%)  1 0/170 (0.00%)  0
Paranoia † 1  1/168 (0.60%)  1 0/170 (0.00%)  0
Alcohol Use Disorder † 1  1/168 (0.60%)  1 0/170 (0.00%)  0
1
Term from vocabulary, MedDRA (16.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sugar Pill Gabapentin Enacarbil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   155/168 (92.26%)      157/170 (92.35%)    
Gastrointestinal disorders     
Diarrhea † 1  10/168 (5.95%)  11/170 (6.47%) 
Nausea † 1  23/168 (13.69%)  17/170 (10.00%) 
Vomiting † 1  8/168 (4.76%)  15/170 (8.82%) 
General disorders     
Fatigue † 1  26/168 (15.48%)  44/170 (25.88%) 
Infections and infestations     
Nasopharyngitis † 1  21/168 (12.50%)  19/170 (11.18%) 
Upper respiratory tract infection † 1  17/168 (10.12%)  22/170 (12.94%) 
Investigations     
Blood Pressure diastolic increased † 1  42/168 (25.00%)  43/170 (25.29%) 
Blood Pressure Systolic increase † 1  32/168 (19.05%)  33/170 (19.41%) 
Aspartate Aminotransferase Increased † 1  26/168 (15.48%)  24/170 (14.12%) 
Gamma-glutamyltransferase increased † 1  19/168 (11.31%)  30/170 (17.65%) 
Alanine aminotransferase increased † 1  19/168 (11.31%)  14/170 (8.24%) 
Blood creatinine increased † 1  8/168 (4.76%)  14/170 (8.24%) 
Blood bilirubin increased † 1  9/168 (5.36%)  10/170 (5.88%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1  19/168 (11.31%)  11/170 (6.47%) 
Arthralgia † 1  14/168 (8.33%)  5/170 (2.94%) 
Nervous system disorders     
Headache † 1  47/168 (27.98%)  38/170 (22.35%) 
Dizziness † 1  23/168 (13.69%)  36/170 (21.18%) 
Somnolence † 1  16/168 (9.52%)  30/170 (17.65%) 
Insomnia † 1  17/168 (10.12%)  18/170 (10.59%) 
Paraesthesia † 1  6/168 (3.57%)  11/170 (6.47%) 
Tremor † 1  1/168 (0.60%)  10/170 (5.88%) 
Psychiatric disorders     
Anxiety † 1  7/168 (4.17%)  14/170 (8.24%) 
Abnormal dreams † 1  9/168 (5.36%)  6/170 (3.53%) 
Agitation † 1  3/168 (1.79%)  9/170 (5.29%) 
Depressed mood † 1  9/168 (5.36%)  3/170 (1.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  6/168 (3.57%)  13/170 (7.65%) 
Skin and subcutaneous tissue disorders     
Rash † 1  13/168 (7.74%)  2/170 (1.18%) 
Pruritus † 1  10/168 (5.95%)  3/170 (1.76%) 
1
Term from vocabulary, MedDRA (16.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Restricts disclosure until the main study paper is published.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Megan Ryan
Organization: NIAAA
Phone: 3014434225
EMail: mryan1@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT02252536    
Other Study ID Numbers: NCIG - 006
First Submitted: September 26, 2014
First Posted: September 30, 2014
Results First Submitted: April 9, 2018
Results First Posted: September 21, 2018
Last Update Posted: November 14, 2018