Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Medical University of South Carolina.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical University of South Carolina
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00183196
First received: September 13, 2005
Last updated: December 9, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Naltrexone Drug: Naltrexone plus Gabapentin Other: Inactive Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Gabapentin as an Adjunct to Naltrexone for Alcoholism |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
Primary Outcome Measures:
- Time to relapse to drinking [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Symptoms such as difficulty falling asleep and/or staying asleep, irritability and nervousness as measured by a symptom checklist and specific scales. [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percent days drinking [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Drinks per drinking day [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Retention in the protocol [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Craving for alcohol [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- CDT and GGT measured as change from baseline [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Psychological and general health functioning as measured by the Beck Anxiety and Depression scales [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Consequences of drinking as measured by the DRINC score at week 16 [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Urinary riboflavin as a measure of medication compliance [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
- Measure: Liver function tests (ALT and AST) [ Time Frame: 16 weeks, 28 and 40 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Naltrexone plus placebo
|
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
|
|
Active Comparator: 2
naltrexone + gabapentin
|
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
|
|
Sham Comparator: 3
Placebo plus placebo
|
Other: Inactive Placebo
Placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183196
Locations
| United States, South Carolina | |
| Medical University of South Carolina, Center for Drug and Alcohol Programs | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Medical University of South Carolina
Investigators
| Principal Investigator: | Raymond F. Anton, MD | Medical University of South Carolina |
More Information
No publications provided by Medical University of South Carolina
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Raymond F. Anton, MD, Principal Investigator, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00183196 History of Changes |
| Other Study ID Numbers: | NIAAAANT09568-2005a, 5R01AA009568-14, NIH RO1 AA09568 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Medical University of South Carolina:
|
Alcohol dependence Alcoholism Heavy drinking |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Gabapentin Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 16, 2013