Overview

This trial is active, not recruiting.

Conditions alcoholism, depression, ptsd
Treatment paroxetine, desipramine, naltrexone
Phase phase 3
Sponsor Elizabeth Ralevski
Start date October 2001
End date October 2014
Trial size 120 participants
Trial identifier NCT00338962, HIC # 11637

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Paxil plus either naltrexone or placebo
paroxetine, desipramine, naltrexone
paroxetine (40mg/day) plus either naltrexone (600mg/week) or placebo desipramine (200mg/day) plus either naltrexone (600mg/week) or placebo
(Active Comparator)
Desipramine plus naltrexone or placebo
paroxetine, desipramine, naltrexone
paroxetine (40mg/day) plus either naltrexone (600mg/week) or placebo desipramine (200mg/day) plus either naltrexone (600mg/week) or placebo

Primary Outcomes

Measure
self-report weekly alcohol consumption
time frame: 12 weeks
self-report weekly craving
time frame: 12 weeks
weekly psychiatric and emotional distress
time frame: 12 weeks
weekly psychiatric symptoms of depression and PTSD
time frame: 12 weeks
side effects
time frame: 12 weeks

Secondary Outcomes

Measure
weekly quality of life
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Naltrexone & SSRI in Alcoholics With Depression/PTSD
Principal investigator Ismene Petrakis, M.D.
Description OBJECTIVE: Alcoholics with current comorbid mental disorders constitute the majority of alcoholics in clinical settings. Although there are two FDA approved medications for the treatment of alcoholism (naltrexone and disulfiram), there are no established pharmacotherapies for individuals with comorbid alcoholism and psychiatric illnesses. Studies suggest that the class of antidepressants known as serotonin selective reuptake inhibitors (SSRIs) is effective in reducing alcohol use in depressed individuals. In addition, a small open label study has shown that SSRIs have similar effects on individuals with comorbid PTSD and alcoholism. Preclinical studies have shown that the combination of a serotonergic agent and naltrexone was more effective than either medication alone in suppressing alcohol intake. To address this issue, we are conducting a 13 week randomized clinical trial evaluating the effects of paroxetine, desipramine and naltrexone in reducing alcohol use in alcohol dependent individuals who currently meet DSM-IV diagnosis for Depressive Disorder or PTSD. RESEARCH PLAN: One hundred and twenty subjects who are alcohol dependent patients with comorbid PTSD or Depressive Disorder will be recruited from the following West Haven VA sources: the Substance Abuse Treatment program, the PTSD clinic, the Women's clinic, clinical referrals and advertisement. These subjects will be randomized in a double-blind fashion to one of four cells. We will compare paroxetine versus desipramine and naltrexone versus placebo. The antidepressant will be started at a low dose and titrated upward on a fixed schedule. The target dose will be 40mg for paroxetine and 200mg for desipramine. Minimum dosage permitted for study retention will be 20mg for paroxetine and 150mg for desipramine. Pharmacological treatments will last 13 weeks. Psychosocial treatment will involve medication compliance therapy, using the Microelectric Event Monitoring (MEMS) bottle caps. The specific aim of the research is to compare the relative effectiveness of paroxetine versus desipramine and naltrexone versus placebo in reducing the quantity and frequency of alcohol consumption. METHODOLOGY: The primary outcome measures of major interest will include: frequency and quantity of alcohol consumption, self-reported craving, self-reported psychiatric and emotional distress, diagnostic assessment or psychiatric symptoms and side effects. These outcomes will be measured by the following: self-assessments, Timeline Followback, Hamilton Depression and anxiety scales, CAPS, ASI, Quality of Life, breathalyzer tests and monthly liver function tests.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Yale University.