Expired Study
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New York, New York 10032


Purpose:

The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome. It is hypothesized that quetiapine will decrease marijuana withdrawal and relapse. Primary outcome measures will be 1. marijuana's direct effects 2. marijuana withdrawal syndromes 3. marijuana relapse. It is also hypothesized that marijuana withdrawal will be associated with increased levels of stress hormones. A secondary measure will be salivary cortisol.


Study summary:

Quetiapine improves sleep and reduces anxiety and irritability, which are symptoms of marijuana withdrawal. Further, there are case reports showing that marijuana-dependent schizophrenics maintained on quetiapine had a 97.3% reduction in marijuana use. Thus, the purpose of this study is to determine if quetiapine decreases marijuana's direct effects, symptoms of marijuana withdrawal and marijuana relapse in the laboratory. The study will utilize and inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.


Criteria:

Inclusion Criteria: - Current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per week for the past 4 weeks - Able to perform study procedures - 21-45 years of age - Women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, IUD) - Normal body weight Exclusion Criteria: - Current, repeated illicit drug use (other than marijuana) - Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant abnormalities) - History of heart disease or current conduction system disease as indicated by QRS duration > 0.11 - Request for drug treatment - Current parole or probation - Pregnancy or current lactation - Recent history of significant violent behavior - Major current Axis I psychopathology (major depressive disorder, bipolar disorder, suicide risk, schizophrenia) - Current use of any prescription or over-the-counter medication - Prior allergic or otherwise serious adverse reaction to quetiapine


NCT ID:

NCT00743366


Primary Contact:

Principal Investigator
Margaret Haney, Ph.D
New York State Psychiatric Institute


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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