drugset / Trial / NCT01468012

Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence

NCT01468012

Phase 2/3 Completed 23 enrolled New York State Psychiatric Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE may reverse baseline brain deficits and if this change is associated with clinical improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence from cocaine over a 12-week trial in combination with behavioral treatment with voucher incentives.

Timeline

Start
2014-07
Primary completion
2014-07
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbidopa Unknown 100 mg
Subject Entacapone Small molecule 200 mg
Subject Levodopa Small molecule 400 mg

Indications