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Quetiapine for Cocaine Use and Cravings

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00232336
First received: September 30, 2005
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Cocaine-Related Disorders
Substance-Related Disorders
Drug: quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • score on a self-report measure of cocaine use at 6 weeks [ Time Frame: after 6 weeks treatment ]
  • score on a self-report measure of cocaine cravings at 6 wks [ Time Frame: after 6 weeks treatment ]
  • results from urine drug screens across 6 weeks [ Time Frame: weekly ]

Secondary Outcome Measures:
  • addiction severity [ Time Frame: after 6 weeks treatment ]

Enrollment: 42
Study Start Date: October 2003
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232336

Locations
United States, Washington
VA Puget Sound Health Care System, American Lake Division
Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
AstraZeneca
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232336     History of Changes
Other Study ID Numbers: TA 1 26, IRUS QUET0297
Study First Received: September 30, 2005
Last Updated: July 29, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
cocaine
drug
substance
abuse
addiction
dependence
quetiapine
antipsychotic
treatment

Additional relevant MeSH terms:
Cocaine-Related Disorders
Disease
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Cocaine
Quetiapine
Anesthetics
Anesthetics, Local
Antipsychotic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014