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Sponsors and Collaborators: |
Seattle Institute for Biomedical and Clinical Research VA Puget Sound Health Care System AstraZeneca |
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Information provided by: | Seattle Institute for Biomedical and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00631748 |
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.
Condition | Intervention |
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Cocaine Dependence Cocaine Abuse Cocaine Addiction Drug Abuse Substance Abuse |
Drug: quetiapine fumarate Drug: Matched Placebo Behavioral: Cognitive-behavioral Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Trial of the Efficacy of Quetiapine for the Reduction of Cocaine Use |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Study Drug: Experimental |
Drug: quetiapine fumarate
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.
Behavioral: Cognitive-behavioral Therapy
During the 12 week treatment phase, all subjects will also attend weekly group cognitive-behavioral therapy sessions. This therapy platform will utilize the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety was originally designed as a psychotherapeutic intervention for women dually diagnosed with PTSD and substance abuse disorders but it has also been successfully used with dually diagnosed men. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations. In addition, Seeking Safety has been shown to be as effective as cognitive-behavioral relapse prevention therapy. Seeking Safety's focus on increasing emotional regulation and teaching cognitive, behavioral and interpersonal coping skills that provide ready alternatives to substance use make it an appropriate psychotherapeutic intervention for any person in early recovery from a substance use disorder.
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Placebo: Placebo Comparator |
Drug: Matched Placebo
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.
Behavioral: Cognitive-behavioral Therapy
During the 12 week treatment phase, all subjects will also attend weekly group cognitive-behavioral therapy sessions. This therapy platform will utilize the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety was originally designed as a psychotherapeutic intervention for women dually diagnosed with PTSD and substance abuse disorders but it has also been successfully used with dually diagnosed men. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations. In addition, Seeking Safety has been shown to be as effective as cognitive-behavioral relapse prevention therapy. Seeking Safety's focus on increasing emotional regulation and teaching cognitive, behavioral and interpersonal coping skills that provide ready alternatives to substance use make it an appropriate psychotherapeutic intervention for any person in early recovery from a substance use disorder.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Annette Kennedy, PsyD | 253-583-1614 | Annette.Kennedy@va.gov |
Contact: Ann Goldberg, BA | 253-583-1671 | Ann.Goldberg2@va.gov |
United States, Washington | |
VA Puget Sound Health Care System | Recruiting |
Tacoma, Washington, United States, 98493 | |
Contact: Kennedy 253-583-1614 Annette.Kennedy@va.gov |
Study Director: | Annette Kennedy, PsyD | VA Puget Sound Health Care System |
Responsible Party: | VA Puget Sound Health Care Ssytem ( Andre Tapp, M.D. ) |
Study ID Numbers: | TA1 42, IRUSQUET0449 |
Study First Received: | March 3, 2008 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00631748 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
cocaine quetiapine fumarate dependence |
abuse addiction treatment |
Cocaine-Related Disorders Quetiapine Behavior, Addictive Dopamine |
Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Cocaine |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents |
Antipsychotic Agents Pharmacologic Actions Anesthetics, Local Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |