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

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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)

Brief Summary:
The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: gabapentin enacarbil Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder
Study Start Date : June 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Placebo Comparator: Sugar Pill
Matching placebo, sugar pill
Drug: Placebo
Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

Active Comparator: Gabapentin Enacarbil
600 mg Gabapentin Enacarbil (Horizant)
Drug: gabapentin enacarbil
Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Other Name: Horizant Extended Release Tablets




Primary Outcome Measures :
  1. Percentage of Subjects With no Heavy Drinking Days (PSNHDD) [ Time Frame: 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 Outcome Measures :
  1. Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) [ Time Frame: Weeks 22-25 ]
    Timeline Follow-back drinking data is used to calculate the % of subjects that report not drinking alcohol during weeks 22-25

  2. Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level [ Time Frame: 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


  3. Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels [ Time Frame: 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


  4. Percentage of Days Abstinent Per Week [ Time Frame: Weeks 22-25 ]
    Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week.

  5. Percentage of Heavy Drinking Days Per Week [ Time Frame: 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

  6. Weekly Mean Number of Drinks Per Week [ Time Frame: Weeks 22-25 ]
    Timeline Follow Back data used to calculate the weekly mean number of drinks per week

  7. Weekly Mean Drinks Per Drinking Day [ Time Frame: Weeks 22-25 ]
    Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day

  8. Cigarettes Per Week Among Smokers [ Time Frame: 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)?".

  9. Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)] [ Time Frame: 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


  10. Alcohol Related Consequences (ImBIBe) Score [ Time Frame: Weeks 24 and 26 ]

    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


  11. Pittsburgh Sleep Quality Index (PSQI) Score [ Time Frame: Week 26 ]
    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.

  12. Beck Anxiety Inventory (BAI) Score [ Time Frame: Week 26 ]
    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

  13. Beck Depression Inventory - II [ Time Frame: Week 26 ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet each one of the following inclusion criteria in order to be eligible for participation in the study:

  1. Be at least 21 years of age.
  2. Have a current (past 12 months) DSM-5 diagnosis of AUD.
  3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
  4. Be seeking treatment for problems with alcohol.

Additional will be evaluated in clinic.

Exclusion Criteria:

Evaluations will be conducted in clinic.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252536


Locations
United States, California
University of California Los Angeles
Los Angeles, California, United States
Friends Research Institute
San Francisco, California, United States, 94103
United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai St. Luke's Hospital
New York, New York, United States, 10025
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Arbor Pharmaceuticals, Inc.
Investigators
Study Chair: Raye Z. Litten, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  Study Documents (Full-Text)

Documents provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Study Protocol  [PDF] August 18, 2016
Statistical Analysis Plan  [PDF] August 22, 2016


Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT02252536     History of Changes
Other Study ID Numbers: NCIG - 006
First Posted: September 30, 2014    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
alcohol use disorder
alcoholism
alcohol dependence
drinking alcohol

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Ethanol
Gabapentin
gamma-Aminobutyric Acid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents