Quetiapine for Cocaine Use and Cravings

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborator: AstraZeneca
• Treatments: Cocaine; Quetiapine Fumarate

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.