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CompletedNCT00000456Updated Oct 4, 2010

Behavioral Therapy Plus Naltrexone for Alcoholism

A Phase 4 interventional study of naltrexone (Revia) and cognitive behavior therapy in Alcoholism and Alcohol Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-04.

Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
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Study summary

This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.

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Conditions studied

  • Alcoholism
  • Alcohol Dependence

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Keywords

  • Alcoholism
  • Alcohol Dependence
  • Naltrexone
  • Cognitive Behavioral Therapy
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In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 160 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.

Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification.
  • Consumes on average five standard drinks per day.
  • Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements.
  • Able to read and understand questionnaires and informed consent.
  • Lives within 50 miles of the study site.

Exclusion criteria

Exclusion Criteria:

  • Currently meets criteria for any other psychoactive substance dependency disorder.
  • Ever abused opiates.
  • Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen.
  • Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
  • Meets criteria for dissociate disorder or eating disorders.
  • Has current suicidal or homicidal ideation.
  • Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
  • Current use of disulfiram (Antabuse).
  • Clinically significant medical problems that would impair participation or limit medication ingestion.
  • Hepatocellular disease.
  • Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
  • Have current charges pending for a violent crime.
  • Does not have a stable living situation and a reliable source of collateral reporting.
  • Has taken an opiate antagonist drug in the last month.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Interventions

  • Behavioralcognitive behavior therapy
  • Behavioralmotivational enhancement therapy
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Study locations

1 site
  • Medical Univ. of South Carolina
    Charleston, South Carolina 29425, United States
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References and documents

Publications

  • Anton RF, Moak DH, Latham P, Waid LR, Myrick H, Voronin K, Thevos A, Wang W, Woolson R. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. doi: 10.1097/01.jcp.0000172071.81258.04. PubMed 16012278 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000456
First posted
Nov 3, 1999
Start date
Sep 1992
Primary completion
Aug 2002
Completion
Aug 2002
Last update
Oct 4, 2010

Study contacts

Ray Anton, MD
principal investigator · Medical University of South Carolina
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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