Marijuana Smoking Clinical Trial
Official title:
Effect of Quetiapine on Marijuana Withdrawal and Relapse
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 45 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | marijuana's direct effects | 1 day | No | |
Primary | Marijuana relapse | 4 days | No | |
Secondary | Marijuana Withdrawal | 3 days | No |
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