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Quetiapine for the Reduction of Cocaine Use

NCT00631748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-31

Study results available
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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.

Conditions

  • Cocaine Dependence
  • Cocaine Abuse
  • Cocaine Addiction
  • Drug Abuse
  • Substance Abuse

Interventions

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.

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 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.

Sponsors & Collaborators

  • VA Puget Sound Health Care System

    collaborator FED

  • AstraZeneca

    collaborator INDUSTRY

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Andre M Tapp, MD · VA Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631748 on ClinicalTrials.gov