- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00743366
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quetiapine (200mg/day), Marijuana (6.2%, 0.0%)
Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day ((1100 and 2300 hours). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
0,6.2% THC
Other Names:
200 mg/day
Other Names:
|
Placebo Comparator: Placebo, Marijuana (6.2%, 0.0%)
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion.
Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
|
0,6.2% THC
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
Time Frame: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
|
This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value. |
Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Margaret Haney, Ph.D, New York State Psychiatric Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Marijuana Use
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Vitamins
- Vitamin B Complex
- Quetiapine Fumarate
- Riboflavin
Other Study ID Numbers
- 5685
- 5P50DA009236 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Marijuana Smoking
-
Western University, CanadaRecruitingCannabis Use | Marijuana Smoking | Cannabis Smoking | Marijuana UsageCanada
-
RANDNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Drinking | Cigarette Smoking | Marijuana SmokingUnited States
-
Yale UniversityCompleted
-
Yale UniversityCompleted
-
Pacific Institute for Research and EvaluationCompletedSmoking | Alcohol Drinking | Marijuana SmokingUnited States
-
Brown UniversityCompleted
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...CompletedMarijuana SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)Completed
-
State University of New York at BuffaloCompleted
-
National Institute on Drug Abuse (NIDA)Completed
Clinical Trials on Marijuana
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedMarijuana DependenceUnited States
-
Hartford HospitalYale UniversityRecruiting
-
National Jewish HealthColorado Department of Public Health and EnvironmentUnknown
-
University of California, San DiegoCompletedCannabis | Pain Syndrome | HIV NeuropathyUnited States
-
Center for Medicinal Cannabis ResearchCompletedHIV Infections | Peripheral Nervous System DiseasesUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA); RTI International; National Institute...CompletedBehavioral Pharmacology of CannabisUnited States
-
University of California, San DiegoCompletedCannabis IntoxicationUnited States
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); University of MinnesotaCompletedSickle Cell DiseaseUnited States
-
Unity Health TorontoUniversity Health Network, TorontoUnknown
-
Children's Hospital of PhiladelphiaWithdrawnInflammatory Bowel Diseases | Neuropathic Pain