Marijuana Drug Discrimination and Self-Administration
DDC
Smoked Marijuana Discrimination and Marijuana Choice in Humans: A Laboratory Mode
2 other identifiers
observational
29
1 country
1
Brief Summary
This study is designed to investigate the associations among marijuana's discriminative stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the relative ability of oral THC to block these effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 28, 2016
April 1, 2016
3.7 years
July 21, 2009
April 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To test the ability of oral THC to alter the discriminative stimulus and reinforcing effects of smoked marijuana.
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.
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.
Secondary Outcomes (1)
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.
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.
Study Arms (1)
Marijuana-dependent volunteers
Interventions
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.
Eligibility Criteria
Marijuana dependent volunteers
You may qualify if:
- Female and male volunteers must be in generally good health (as indicated by results from medical history, physical exam, electrocardiogram, urine and blood samples at screening and upon arrival at the laboratory (urine samples only).
- Psychiatric examination must meet DSM-IV criteria for Cannabis Dependence.
- Individuals must be legally and mentally competent to provide written informed consent.
- Those who are unable to give their voluntary informed consent will not be accepted.
You may not qualify if:
- Current serious Axis I disorder (except Cannabis or Nicotine Dependence), neurologic, cardiovascular, pulmonary or systemic (e.g., renal, hepatic) disease; cognitive impairment; pregnancy (urine test), lactation (self-report), or not using (self-report) medically approved contraceptives.
- Applicants who express interest in treatment will not be accepted for study and will be provided with a treatment referral.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wayne State Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Wayne State University
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Lundahl, PhD
Wayne State University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 22, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2014
Last Updated
April 28, 2016
Record last verified: 2016-04