Naltrexone & SSRI in Alcoholics With Depression/PTSD

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Desipramine; Naltrexone; Paroxetine

Criteria

Inclusion Criteria:

• DSM-IV diagnosis of alcohol dependence and current DSM-IV depressive disorder or PTSD

• a recent episode of heavy drinking

• outpatient, sober from alcohol and other abused substance for at least 2 days before randomization

• stable medication regiment for at least 2 weeks

• women on adequate methods of contraception

Exclusion Criteria:

• current opioid dependence or abuse

• history (within the last 3 months) of opioid dependence or abuse

• pregnant

• history of psychotic disorders or current treatment with antipsychotic medications

• medication thought to influence drinking including: acamprosate, disulfiram, naltrexone, ondansetron, valproic acid or tegretol

• current (within the lst 6 months) use of MAO inhibitors

• suicidal active ideation or intent

• significant underlying medical condition

• history of cardiac condition abnormalities