Quetiapine for Cocaine Use and Cravings

NCT00232336 | Completed Phase 4

• 2 other identifiers: TA 1 26IRUS QUET0297
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Keywords

cocaine; drug; substance; abuse; addiction; dependence; quetiapine; antipsychotic; treatment

Outcome Measures

Primary Outcomes (3)

• score on a self-report measure of cocaine use at 6 weeks

  after 6 weeks treatment

• score on a self-report measure of cocaine cravings at 6 wks

  after 6 weeks treatment

• results from urine drug screens across 6 weeks

  weekly

Secondary Outcomes (1)

• addiction severity

  after 6 weeks treatment

Interventions

quetiapine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• DSM-IV diagnosis of cocaine dependence without psychotic symptoms
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• AstraZeneca: collaborator

Study Sites (1)

VA Puget Sound Health Care System, American Lake Division

Tacoma, Washington, 98493, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Behavior, Addictive

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: October 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

US (1)