Clinical trial NCT00631748
Conditions: Cocaine Dependence Cocaine Abuse Cocaine Addiction Drug Abuse Substance Abuse
Keywords: cocaine quetiapine fumarate dependence abuse addiction treatment
Sponsor: Seattle Institute for Biomedical and Clinical Research
Start date: 2008-02-01; Completion date: 2010-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
Cocaine abuse continues to be an epidemic. Co-morbid psychiatric disorders and high risks behaviors compound the morbidity, economic costs, and social destruction associated with this public health crisis. This is a 12 week, prospective, intent-to-treat, double-blind, randomized, placebo-controlled study of Seroquel XR™ versus matched placebo, combined with cognitive-behavioral group therapy, for the treatment of cocaine dependence in non-psychotic individuals.

We will conduct this study at the American Lake (Tacoma) and Seattle campuses of the VA Puget Sound Health Care System, recruiting veteran and non-veteran participants currently using cocaine from the greater Pierce and King Counties region. It is anticipated that 120 subjects will be consented and screened for study participation and that 60 subjects will be randomized to treatment.

After subjects have provided informed consent, they will enter a 1 week screening phase during which medical, psychiatric, and substance use measures and assessments will be administered to determine study eligibility. At baseline, we will assess cocaine use, cocaine craving, psychiatric symptoms, and high risk behaviors. Also at this visit, subjects will be randomly assigned to treatment with quetiapine (target dose 400 mg/day) or placebo. During the treatment phase, subjects will visit the clinic once a week for safety monitoring, completion of ratings and questionnaires, UDS's, and participation in a cognitive-behavioral therapy group. At end of study, week 12, a physical examination will be administered and a UDS and clinical laboratory values obtained. In addition, substance use, psychiatric symptoms, and high risk behaviors will be assessed. To monitor safety and further evaluate treatment effects, we will ask participants to return for a follow-up visit at week 16.

Arms: arm 1: Subjects randomized to the experimental arm of the study will be initially administered 50mg/day quetiapine fumarate (Seroquel XR) to be titrated up to 400mg/day by the end of the second week. Subjects will be stabilized at a dose of 400mg/day or alternatively 300, 200, 100, or 50mg/day or quetiapine fumarate as tolerated. 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. arm 2: Subjects randomized to the placebo arm of the study will follow the same titration and dosing procedure as the experimental arm 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.
Interventions: intervention 1: quetiapine fumarate intervention 2: Matched Placebo intervention 3: Cognitive-behavioral Therapy
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol documents: