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Sertraline and Naltrexone for Alcohol Dependence

Sertraline and Naltrexone for Alcohol Dependents

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000440
Enrollment
124
Registered
1999-11-03
Start date
Unknown
Completion date
2002-09-30
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

This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).

Interventions

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 55 Years
Healthy volunteers
No

Inclusion criteria

* Meets the criteria for alcohol dependence. * Abstinent from alcohol for a period of at least 5 days and not greater than 30 days. * Able to read English and complete study evaluations. * A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion criteria

* Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence. * Current use of disulfiram (Antabuse) or a MAO Inhibitor. * Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania). * Major depression at the time of assessment. * Previous treatment with naltrexone (Revia) for alcohol dependence. * Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease. * Abstinent longer than 30 days prior to admission to program. * Hepatocellular disease or elevated bilirubin levels. * Females who are pregnant, nursing, or not using a reliable method of birth control.

Countries

United States

Outcome results

None listed

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