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Naltrexone Treatment of Alcohol Dependence

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000452
Enrollment
240
Registered
1999-11-03
Start date
Unknown
Completion date
2003-01-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Brief summary

The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management.

Interventions

BEHAVIORALCompliance Enhancement Tech.
BEHAVIORALCognitive Behavior Therapy

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Meets criteria for current diagnosis of alcohol dependence. * Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days. * Successful completion of medical detoxification. * Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits. * Understands and signs the informed consent.

Exclusion criteria

* Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana. * Evidence of opiate use in the past 30 days. * Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification). * History of unstable or serious medical illness, including need for opioid analgesics. * Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms. * Use of an investigation medication in the past 30 days. * Female subjects who are pregnant, nursing, or not using reliable method of contraception.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026