At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled Trial of the Efficacy of Quetiapine for the Reduction of Cocaine Use
In Brief
A clinical study evaluating quetiapine fumarate, Matched Placebo, and 1 other intervention for Cocaine Dependence and 4 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This placebo-controlled trial will test the effectiveness of Seroquel XR™ for the treatment of cocaine dependence in non-psychotic individuals who are cocaine dependent.
Study Details
Timeline
Interventions
At baseline, subjects in the experimental group will initially be administered 50 mg/day of Seroquel XR™ (extended release formulation of quetiapine fumarate), to be titrated up to 400 mg/day of Seroquel XR™ by the end of the second week. By the end of week 2, subjects will be stabilized on a dose of 400 mg/day or alternatively 300, 200, 100, or 50 mg/day of study drug, as tolerated. If a subject is unable to tolerate the 50 mg/day dose, he or she will be discontinued from the drug portion of the study.
Subjects randomized to the placebo comparator group will follow the same titration and dosing procedures as the experimental group, but will receive matched placebo tablets.
During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.