Aims Whether the selective serotonin re-uptake inhibitor sertraline at 200 mg/day delays relapse in recently abstinent cocaine-dependent individuals.
Design The study involved a 12-week, double-blind, placebo-controlled clinical trial with 2-week residential stay followed by 10-week out-patient participation.
Setting Veterans Affairs residential unit and out-patient treatment research program.
Participants Cocaine-dependent volunteers (n = 86) with depressive symptoms (Hamilton score > 15), but otherwise no major psychiatric or medical disorder or contraindication to sertraline.
Measurements Participants were housed on a drug-free residential unit (weeks 1–2) and randomized to receive sertraline or placebo. Participants then participated on an out-patient basis during weeks 3–12 while continuing to receive study medication. Patients participated in a day substance abuse/day treatment program during weeks 1–3 and underwent weekly cognitive behavioral therapy during weeks 4–12. The primary outcome measure was thrice-weekly urine results and the secondary measure was Hamilton Depression scores.
Findings Pre-hoc analyses were performed on those who participated beyond week 2. Generally, no group differences in retention or baseline characteristics occurred. Sertraline patients showed a trend towards longer time before their first cocaine-positive urine (‘lapse’, χ2 = 3.67, P = 0.056), went significantly longer before having two consecutive urine samples positive for cocaine (‘relapse’, χ2 = 4.03, P = 0.04) and showed significantly more days to lapse (26.1 ± 16.7 versus 13.2 ± 10.5; Z = 2.89, P = 0.004) and relapse (21.3 ± 10.8 versus 32.3 ± 14.9; Z = 2.25, P = 0.02). Depression scores decreased over time (F = 43.43, P < 0.0001), but did not differ between groups (F = 0.09, P = 0.77).
Conclusions Sertraline delays time to relapse relative to placebo in cocaine-dependent patients who initially achieve at least 2 weeks of abstinence.