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Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00183196
First received: September 13, 2005
Last updated: April 23, 2013
Last verified: January 2013

September 13, 2005
April 23, 2013
January 2003
December 2008   (final data collection date for primary outcome measure)
Time to Relapse to Drinking [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Time to relapse drinking which is 5 standard drinks for males and 4 standard drinks for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.
  • - Time to relapse to drinking.
  • - Symptoms such as difficulty falling asleep and/or staying asleep, irritability and nervousness as measured by a symptom checklist and specific scales.
Complete list of historical versions of study NCT00183196 on ClinicalTrials.gov Archive Site
Not Provided
  • - Percent days drinking
  • - Drinks per drinking day
  • - Retention in the protocol
  • - Craving for alcohol
  • - CDT and GGT measured as change from baseline
  • - Psychological and general health functioning as measured by the Beck Anxiety and Depression scales
  • - Rand SF-36
  • - Consequences of drinking as measured by the DRINC score at week 16
  • - Urinary riboflavin as a measure of medication compliance
  • - Profile of Mood States Subscales
Not Provided
Not Provided
 
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Gabapentin as an Adjunct to Naltrexone for Alcoholism

The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.

Subjects will enter the trial after maintaining 4 days of abstinence. During this period multiple assessments will be collected. After entering the double blind treatment portion of the study, they will be evaluated weekly for the first month, then bi-weekly until week 12 and again at week 16. There will be two follow-up visits at weeks 28 and 40. Urinary riboflavin and pill counts will be utilized to determine compliance with the medication regime.

Comparison(s): Naltrexone (50 mg/day) alone for 16-weeks; naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks, or inactive placebos. All subjects will receive up to 20 sessions of individual alcohol counseling.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: Naltrexone
    Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
  • Drug: Naltrexone plus Gabapentin
    naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
  • Other: Inactive Placebo
    Placebo
  • Active Comparator: 1
    Naltrexone plus placebo
    Intervention: Drug: Naltrexone
  • Active Comparator: 2
    naltrexone + gabapentin
    Intervention: Drug: Naltrexone plus Gabapentin
  • Sham Comparator: 3
    Placebo plus placebo
    Intervention: Other: Inactive Placebo
Anton RF, Myrick H, Wright TM, Latham PK, Baros AM, Waid LR, Randall PK. Gabapentin combined with naltrexone for the treatment of alcohol dependence. Am J Psychiatry. 2011 Jul;168(7):709-17. doi: 10.1176/appi.ajp.2011.10101436. Epub 2011 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet criteria for primary alcohol dependence including loss of control of drinking
  • No more than one previous inpatient medical detoxification
  • Consumes on average 5 standard drinks for men and 4 standard drinks for women
  • Able to maintain sobriety for 4 days (with or without detox medications).
  • Able to read and understand questionnaires and Informed Consent
  • Lives within 50 miles of the study site

Exclusion Criteria:

  • Currently meets DSM-IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
  • Ever abused opiates
  • Any psychoactive substance abuse, except marijuana and nicotine within the last 30 days as evidenced by subject report, collateral report, or urine drug screen.
  • Meets DSM-IV criteria for current Axis I disorder of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, dissociative disorder or eating disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
  • Has current suicidal or homicidal ideation
  • Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
  • Current use of disulfiram.
  • Clinically significant medical problems, such as cardiovascular, renal, GI or endocrine problem that would impair participation or limit medication ingestion.
  • Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days of abstinence.
  • Sexually active females of child bearing potential who are pregnant (by urine HCG), nursing or who are not using a reliable form of birth control.
  • Has current charges pending for a violent crime (not including DUI related offenses).
  • Does not have a stable living situation and a reliable source of collateral reporting.
  • Has taken an opiate antagonist drug in the last month.
  • Has taken gabapentin in the last month or has experienced adverse effects from it at any time in the past.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183196
NIAAAANT09568-2005a, 5R01AA009568-14, NIH RO1 AA09568
No
Raymond F. Anton, Medical University of South Carolina
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Raymond F. Anton, MD Medical University of South Carolina
Medical University of South Carolina
January 2013

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