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Quetiapine for Cocaine Use and Cravings

Primary Purpose

Cocaine-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
quetiapine
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine, drug, substance, abuse, addiction, dependence, quetiapine, antipsychotic, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Puget Sound Health Care System, American Lake Division

Outcomes

Primary Outcome Measures

score on a self-report measure of cocaine use at 6 weeks
score on a self-report measure of cocaine cravings at 6 wks
results from urine drug screens across 6 weeks

Secondary Outcome Measures

addiction severity

Full Information

First Posted
September 30, 2005
Last Updated
July 29, 2008
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00232336
Brief Title
Quetiapine for Cocaine Use and Cravings
Official Title
Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
Keywords
cocaine, drug, substance, abuse, addiction, dependence, quetiapine, antipsychotic, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
quetiapine
Primary Outcome Measure Information:
Title
score on a self-report measure of cocaine use at 6 weeks
Time Frame
after 6 weeks treatment
Title
score on a self-report measure of cocaine cravings at 6 wks
Time Frame
after 6 weeks treatment
Title
results from urine drug screens across 6 weeks
Time Frame
weekly
Secondary Outcome Measure Information:
Title
addiction severity
Time Frame
after 6 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Tapp, M.D.
Organizational Affiliation
VA Puget Sound Health Care System, Tacoma and Seattle, WA and University of Washington, Department of Psychiatry and Behavioral Sciences, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System, American Lake Division
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

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Quetiapine for Cocaine Use and Cravings

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