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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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