Quetiapine for Cocaine Use and Cravings (NCT00232336) | Clinical Trial Compass
CompletedPhase 4
Quetiapine for Cocaine Use and Cravings
United States42 participantsStarted 2003-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
What they're measuring
1
score on a self-report measure of cocaine use at 6 weeks
Timeframe: after 6 weeks treatment
2
score on a self-report measure of cocaine cravings at 6 wks
Timeframe: after 6 weeks treatment
3
results from urine drug screens across 6 weeks
Timeframe: weekly
Trial details
NCT IDNCT00232336
SponsorSeattle Institute for Biomedical and Clinical Research