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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)

Tracking Information
First Submitted Date  ICMJE September 26, 2014
First Posted Date  ICMJE September 30, 2014
Results First Submitted Date  ICMJE April 9, 2018
Results First Posted Date  ICMJE September 21, 2018
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2014)
Percentage of Subjects With no Heavy Drinking Days (PSNHDD) [ Time Frame: Weeks 18-25 ]
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 8 weeks of treatment, among patients with Alcohol Use Disorder (AUD).
Change History Complete list of historical versions of study NCT02252536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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)?".
  • 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
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day
Study Arms  ICMJE
  • Placebo Comparator: Sugar Pill
    Matching placebo, sugar pill
    Intervention: Drug: Placebo
  • Active Comparator: Gabapentin Enacarbil
    600 mg Gabapentin Enacarbil (Horizant)
    Intervention: Drug: gabapentin enacarbil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2014)
346
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02252536
Other Study ID Numbers  ICMJE NCIG - 006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Arbor Pharmaceuticals, Inc.
Investigators  ICMJE
Study Chair: Raye Z. Litten, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP