Quetiapine for Cocaine Use and Cravings
|First Received Date ICMJE||September 30, 2005|
|Last Updated Date||July 29, 2008|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00232336 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||addiction severity [ Time Frame: after 6 weeks treatment ]|
|Original Secondary Outcome Measures ICMJE
||score on a measure of addiction severity at 6 weeks|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Quetiapine for Cocaine Use and Cravings|
|Official Title ICMJE||Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence|
The purpose of this study was to collect pilot data on whether quetiapine may be effective in the reduction of cocaine use and cravings in cocaine dependent individuals.
Dopaminergic and serotonergic neurotransmitter systems are involved in cocaine use and cravings. Atypical antipsychotics act on these neurotransmitter systems, and therefore, may be beneficial in the treatment of cocaine addiction. This open label study assessed the efficacy of quetiapine for the treatment of cocaine use and craving in non-psychotic, cocaine dependent participants over 6 weeks of treatment. The primary outcome measures included self-report of cocaine use and self-report of cocaine cravings. This study also evaluated whether the severity of addiction predicts quetiapine efficacy.
Males and females, ages 18 - 65, with a DSM IV diagnosis of cocaine dependence were recruited for an open label trial of quetiapine dosed at 300-600 mg/day, with a target dose of 600 mg/day. Subjects were followed at weekly study visits to monitor general psychiatric and physical status, medication compliance, efficacy, and adverse events. Study participation included psychiatric and medical examinations, an electrocardiogram, an eye exam, laboratory tests, urine drug screens, electrocardiograms, and psychiatric and substance abuse interviews.
Twenty-three males were initiated on quetiapine treatment, the following results include the first twenty-two study completers. Twenty-two males (36-56 years) diagnosed with cocaine dependence without a psychotic disorder, were initiated on a six-week, open-label trial of quetiapine, 300-600 mg/day (QHS). Five participants discontinued prior to completing the first week of treatment, and 14 of 22 subjects completed the study. The mean dose of quetiapine was 429 mg/day. An intent-to-treat analysis found a significant decrease in cravings on the Brief Substance Craving Scale after six weeks (p < 0.01, Cohen's d = 1.23; repeated measures mixed effects random regression). Cocaine use, addiction severity, and psychopathology also decreased numerically, but not statistically, from baseline to end of study. Adverse effects were generally mild. Addiction severity did not predict quetiapine efficacy. Four subjects withdrew due to sedation; 2 were discontinued by the investigators, and 2 were lost to follow up. Study completers experienced a statistically significant mean weight gain of approximately 4.60 (95% CI, -6.05 - 3.17 kg)(mean baseline weight 86.9 (SD 18.38) kg).
Quetiapine treatment appears to have improved cocaine dependence, specifically cocaine cravings, in non-psychotic individuals. The observed weight change may reflect both weight gain associated with cocaine dependence and medication side effect. Controlled research is warranted to better define the potential role for quetiapine in the treatment of cocaine dependence.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: quetiapine|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00232336|
|Other Study ID Numbers ICMJE||TA 1 26, IRUS QUET0297|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Seattle Institute for Biomedical and Clinical Research|
|Information Provided By||Seattle Institute for Biomedical and Clinical Research|
|Verification Date||July 2008|
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