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Gabapentin for Alcohol Relapse Prevention

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ClinicalTrials.gov Identifier: NCT02349477
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Withdrawal Drug: Gabapentin Drug: Placebo Phase 2

Detailed Description:
This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
Study Start Date : November 2014
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
Gabapentin up to 1200 mg per day in 3 divided doses
Drug: Gabapentin
gaba potentiating medication
Other Name: neurontin

Placebo Comparator: placebo
matching placebo
Drug: Placebo
a pill that looks exactly like the active medication but does not contain medication
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Percent of Subjects With no Heavy Drinking Days (PSNHDD) [ Time Frame: 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 Outcome Measures :
  1. Percent of Subjects With no Drinking Days (PSNDD) [ Time Frame: 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 Outcome Measures:
  1. Number of Participants With No Drinking Days by AWS Score and Medication [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meets criteria for alcohol use disorder based on DSM-5 criteria
  2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
  3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

Exclusion Criteria:

  1. Significant psychiatric or medical illness
  2. No other substance abuse
  3. Taking other medications known to treat alcohol use disorder
  4. Unstable living arrangements
  5. Significant legal problems pending

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): NCT02349477


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Raymond F Anton, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02349477    
Other Study ID Numbers: Pro00032587
First Posted: January 29, 2015    Key Record Dates
Results First Posted: November 4, 2019
Last Update Posted: November 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents