Whether the selective serotonin reuptake inhibitor sertraline at 200 mg/day delays relapse in recently abstinent cocaine dependent individuals
12-week, double blind, placebo-controlled clinical trial with 2-week residential stay followed by 10-wk outpatient participation
Veterans Affairs residential unit and outpatient treatment research program
Cocaine-dependent volunteers (N=86) with depressive symptoms (Hamilton score > 15), but otherwise no major psychiatric or medical disorder or contraindication to sertraline.
Participants were housed on a drug-free residential unit (wks 1–2) and randomized to receive sertraline or placebo. Participants then participated on an outpatient 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 secondary measure was Hamilton Depression scores.
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 toward 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±3.2±10.5; z = 2.89, p=0.004) and relapse (21.3±10.8 vs 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).
Sertraline delays time to relapse relative to placebo in cocaine dependent patients who initially achieve at least two weeks of abstinence.