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Naltrexone & SSRI in Alcoholics With Depression/PTSD

NCT00338962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-02-05

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.

We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.

Conditions

Interventions

DRUG

paroxetine

paroxetine (40mg/day)

DRUG

desipramine

200 mg per day

DRUG

Naltrexone

50 mg per day

DRUG

Placebo

placebo

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Ismene Petrakis, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338962 on ClinicalTrials.gov