Marijuana Drug Discrimination and Self-Administration (DDC)
|ClinicalTrials.gov Identifier: NCT00943930|
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment|
|Marijuana Abuse||Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC|
Volunteers will be asked to live on a research unit for up to twenty-six (26) consecutive nights and will participate in a total of 38 study sessions held on 19 weekdays. Each session will last approximately four hours and there will be two sessions per day, therefore each study day will last approximately eight hours. In addition to these study sessions, an orientation session will be conducted on the Friday prior to admission to the inpatient unit, and a lottery session will be held on the last day of the study.
During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, which is the active ingredient in marijuana responsible for its mood effects), or d-amphetamine. We will have participants answer questions about how the drugs make them feel and measure their vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Smoked Marijuana Discrimination and Marijuana Choice in Humans: A Laboratory Mode|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2014|
Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC
During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, or d-amphetamine.
- To test the ability of oral THC to alter the discriminative stimulus and reinforcing effects of smoked marijuana. [ Time Frame: Multiple Choice Procedure Questionnaire (MCP-Q) will be administered after each drug administration sessions and participants will choose between the drug and various amounts of money. ]Three hours after each smoked marijuana dose the participant will complete the MCP-Q to make 15 independent choices between the drug dose sampled and various money amounts.
- Subjective effects: Self-report questionnaires regarding subjective drug effects, craving, withdrawal symptoms, and marijuana choice will be assessed. Physiological effects: Heart rate, skin temperature, and blood pressure will be monitored. [ Time Frame: Measurements will be taken throughout a total of 40 sessions (i.e., two sessions per day) conducted over 20 weekdays. Total duration of the stay will be up to 30 days, as sessions will not be run on weekends. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943930
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Leslie Lundahl, PhD||Wayne State University|