- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232336
Quetiapine for Cocaine Use and Cravings
Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98493
- VA Puget Sound Health Care System, American Lake Division
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65
- DSM-IV diagnosis of cocaine dependence without psychotic symptoms
- Psychiatrically stable as evidenced by no psychiatric hospitalizations and no changes in psychiatric medications within the prior three months, and as confirmed by clinical interview during the screening phase. (Subjects who are currently hospitalized or have been hospitalized in the past three months for acute cocaine intoxication or withdrawal but who are otherwise psychiatrically stable as defined above are eligible for inclusion.)
- Females must be of non-child bearing potential or on appropriate contraceptive and not breast-feeding.
- Females must have a negative serum beta HCG at screening.
- The subject or his/her legal representative must provide informed, written consent.
Exclusion Criteria:
- Females who are pregnant or lactating
- Concurrent participation or participation within the prior 30 days in any study involving investigational medications
- Current diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
- Use of any antipsychotic medication within the prior three months
- History of idiopathic orthostatic hypotension, or sensitivity to the hypotensive effects of antipsychotic medication
- Angina pectoris or myocardial infarction in the 6 months prior to screening
- Persistent standing heart rate >120bpm or supine tachycardia (heart rate > 100 bpm)
- Sustained cardiac arrhythmia or history of clinically significant cardiac arrhythmia
- Cataracts (as per medical history or examination)
- Known personal history of seizure disorder
- Known history of seizure disorder in first-degree relatives
- History of significant head trauma, defined as head trauma resulting in loss of consciousness for more than five minutes and/or neurological or cognitive sequelae
- Use of potent cytochrome P450 inhibitors or inducers within 14 days before the baseline visit or during treatment, including but not limited to the agents identified in the study protocol
- Barbiturate use (as per self report or positive findings for barbiturates on the screening urine drug assay)
- Evidence of any clinically relevant disease (e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, hepatitis B or C, or cancer) or any clinical finding that in the opinion of the investigator could potentially be negatively affected by study participation or that could potentially affect study participation is criterion for exclusion from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
score on a self-report measure of cocaine use at 6 weeks
Time Frame: after 6 weeks treatment
|
after 6 weeks treatment
|
score on a self-report measure of cocaine cravings at 6 wks
Time Frame: after 6 weeks treatment
|
after 6 weeks treatment
|
results from urine drug screens across 6 weeks
Time Frame: weekly
|
weekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
addiction severity
Time Frame: after 6 weeks treatment
|
after 6 weeks treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andre Tapp, M.D., VA Puget Sound Health Care System, Tacoma and Seattle, WA and University of Washington, Department of Psychiatry and Behavioral Sciences, Seattle, WA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA 1 26
- IRUS QUET0297
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Substance-Related Disorders
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedSubstance-Related Disorders | Substance Use | Substance Use Disorders | Substance Abuse | Substance Dependence | Substance Related Problem
-
US Department of Veterans AffairsCompletedAlcoholism | Substance Use Disorders | Substance Abuse | Alcohol Abuse | Substance DependenceUnited States
-
VA Office of Research and DevelopmentRecruiting
-
National Institute on Drug Abuse (NIDA)CompletedSubstance-related Disorders
-
Norwegian University of Science and TechnologyCompletedSubstance-related DisordersNorway
-
University of Southern CaliforniaNational Institute on Drug Abuse (NIDA)Completed
-
University Hospital, Basel, SwitzerlandPsychiatric Hospital of the University of BaselCompleted
-
University of LuebeckFederal Ministry of Health, GermanyCompletedSubstance-related Disorders
-
University of Illinois at Urbana-ChampaignCompletedSubstance-related Disorders
-
University of NebraskaCompletedSubstance-related Disorders | Alcohol-related DisordersUnited States
Clinical Trials on quetiapine
-
Mayo ClinicCompletedDelirium | DementiaUnited States
-
University of CincinnatiNational Institute on Drug Abuse (NIDA)CompletedBipolar Disorder | Cannabis-Related DisorderUnited States
-
Centro de Investigación Biomédica en Red de Salud...Completed
-
University of CincinnatiNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedBipolar Disorder | Alcohol AbuseUnited States
-
Federal Stare Budgetary Scientific Institution,...Kazan State Medical University; Federal State Budgetary Institution V.M. Bekhterev...RecruitingBipolar Affective DisorderRussian Federation
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Alesund Hospital; Namsos Hospital; Volvat Medisinsk Senter...Recruiting
-
University of CincinnatiCompleted
-
Otsuka Pharmaceutical Development & Commercialization...PRA Health SciencesCompletedSchizophrenia | Bipolar DisorderUnited States
-
University of Texas Southwestern Medical CenterCompletedBipolar Disorder | Cocaine DependenceUnited States
-
The University of Texas Health Science Center at...AstraZenecaCompletedBipolar DisorderUnited States