Conditions: Cocaine Dependence
Keywords: cocaine treatment lisdexamfetamine dependence addiction crack
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

Detailed description:
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

Arms:
arm 1: lisdexamfetamine 70mg/day plus Behavior Therapy arm 2: Placebo Comparator once per day

Interventions: intervention 1: lisdexamfetamine/Behavior Therapy intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: