Phase 3
N=88
Naltrexone & SSRI in Alcoholics With Depression/PTSD
Alcoholism · Depression · PTSD
Bottom Line
View on ClinicalTrials.gov: NCT00338962 ↗Enrolled (actual)
88
Serious AEs
3.4%
Results posted
Feb 2016
Primary outcome: Primary: Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS) — 21.273; 20.700; 18.500; 21.458 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- paroxetine (Drug); desipramine (Drug); Naltrexone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS) |
21.273; 20.700; 18.500; 21.458; 10.013; 9.690 | — |
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
73.54; 69.810; 62.500; 77.833; 40.024; 36.591 | 0.00 sig |
| PRIMARY Hamilton Depression Rating Scale (HAM-D) |
13.273; 10.950; 11.195; 13.167; 9.328; 8.238 | — |
| PRIMARY Mean Number of Side Effects |
3.651; 2.688; 3.052; 3.653; 4.874; 3.963 | 0.007 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00338962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.