A randomized, double-blind, placebo-controlled trial of venlafaxine for the treatment of depressed cocaine-dependent patients

Am J Addict. 2014 Jan-Feb;23(1):68-75. doi: 10.1111/j.1521-0391.2013.12065.x. Epub 2013 Jun 26.

Abstract

Objective: This study tested the hypothesis that the antidepressant venlafaxine would be an effective treatment for cocaine abusers with concurrent depressive disorders.

Methods: This was a randomized, 12-week, double-blind, placebo-controlled trial of outpatients (N = 130) meeting DSM-IIIR criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with venlafaxine, up to 300 mg/day versus placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included Clinical Global Impression Scale (CGI), self-reported cocaine use, urine toxicology and the Hamilton Depression Scale (Ham-D).

Results: Mood response, defined as a 50% reduction in the Ham-D between randomization and end of study, was 41% (26/64) on venlafaxine, and 33% (22/66) on placebo (p = .39). Measures of depression (Ham-D and CGI) improved more rapidly on venlafaxine than placebo, but these differences disappeared by weeks 6-8. Cocaine outcomes did not differ between treatment groups, and the proportion of patients achieving three or more consecutive weeks of urine-confirmed abstinence was low (venlafaxine: 16%; placebo: 15%). Reduction in cocaine use was associated with mood response.

Conclusions: Overall, venlafaxine was not superior to placebo on either mood or cocaine use outcomes. Mood improvement was associated with improvement in cocaine use. However, placebo mood response was only moderate, and the proportion of patients achieving sustained abstinence was low. This suggests that the subgroup of cocaine-dependent patients with depressive disorders is relatively treatment resistant, and that further research is needed to improve outcomes for these patients.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Cocaine-Related Disorders / complications
  • Cocaine-Related Disorders / drug therapy*
  • Cocaine-Related Disorders / therapy
  • Cognitive Behavioral Therapy
  • Combined Modality Therapy
  • Cyclohexanols / therapeutic use*
  • Depressive Disorder / complications
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / prevention & control*
  • Diagnosis, Dual (Psychiatry)
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Recurrence
  • Treatment Outcome
  • Venlafaxine Hydrochloride
  • Young Adult

Substances

  • Antidepressive Agents, Second-Generation
  • Cyclohexanols
  • Venlafaxine Hydrochloride