CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 88 enrolled
Drug / intervention
paroxetine +3 moredrug
Likely dose
paroxetine 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00338962
NCT00338962Phase 3Completed
CompareCT.gov

Naltrexone & SSRI in Alcoholics With Depression/PTSD

Yale University·interventional·Posted Jun 20, 2006·Updated Feb 5, 2016

In Brief

A Phase 3 clinical trial evaluating paroxetine, desipramine, and 2 other interventions for Alcoholism and 2 related conditions. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism, Depression, PTSD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2006
Enrollment StartOct 1, 2001
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 20.0 years ago

Interventions

paroxetinedrug

paroxetine (40mg/day)

desipraminedrug

200 mg per day

Naltrexonedrug

50 mg per day

Placebodrug

placebo