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CONTEXT: Depressive disorders are common among opiate abusers and are associated with detrimental behavioral effects. However, there is little precedent for offering active drug users complex treatments for depression. OBJECTIVE: To determine whether combined psychotherapy and pharmacotherapy treatment reduces reported depressive symptoms compared with an assessment-only condition among out-of-treatment drug injectors. DESIGN: Randomized controlled trial. SETTING: Research office located at an academic medical center. PATIENTS: Active injection drug users with a DSM-IV diagnosis of major depression, dysthymia, substance-induced mood disorder with symptoms persisting for at least 3 months, or major depression plus dysthymia, and a Modified Hamilton Rating Scale for Depression (HAM-D) score greater than 13. INTERVENTION: Combined psychotherapy (8 sessions of cognitive behavior therapy) plus pharmacotherapy (citalopram). MAIN OUTCOME MEASURES: Modified HAM-D scale scores at the end of 3 months of combined treatment. RESULTS: The 109 study subjects were 64% male and had a mean age of 36.7 years and a mean baseline HAM-D score of 20.7. Depression subtypes included major depression only (63%), substance-induced depression (17%), and major depression plus dysthymia (17%). In the intent-to-treat analysis, participants in treatment averaged 2.11 HAM-D points greater improvement than control subjects (P=.08), and 26.1% of combined treatment patients (n=53) compared with 12.5% of control patients (n=56) were in remission (P=.047). Nearly 40% of fully adherent subjects (receiving >75% of either psychotherapy or pharmacotherapy) were in remission at follow-up (odds ratio, 3.6; P=.04). CONCLUSIONS: Combined treatment for depression is significantly superior to a control condition (assessment only) in proportion of patients in remission, but not in HAM-D improvement among drug injectors. Full adherence to treatment is associated with the largest treatment effects. Our findings demonstrate that active drug users with dual diagnoses are able to participate in conventional treatment.