This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication
Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo
Center for the Studies of Addiction
Philadelphia, Pennsylvania, United States
Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
The primary clinical outcome is number of cocaine-use days (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) during the outpatient treatment and follow-up phases of the study.
Time frame: up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.