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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
Wayne State University |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00943930 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Marijuana Abuse |
Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Smoked Marijuana Discrimination and Marijuana Choice in Humans: A Laboratory Mode |
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Marijuana-dependent volunteers |
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.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Marijuana dependent volunteers
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lisa Sulkowski | (313) 993-3966 | lsulkows@med.wayne.edu |
| Contact: Ken Bates | (313) 993-3960 | kbates@med.wayne.edu |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48207 | |
| Contact: Leslie Lundahl, PhD 313-993-1374 llundahl@med.wayne.edu | |
| Principal Investigator: | Leslie Lundahl, PhD | Wayne State University |
More Information
| Responsible Party: | Wayne State University ( Leslie Lundahl, PhD ) |
| Study ID Numbers: | NIDA DA026761, R01DA026761-01 |
| Study First Received: | July 21, 2009 |
| Last Updated: | December 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00943930 History of Changes |
| Health Authority: | United States: Federal Government |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Hallucinogens Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders |
Analgesics Sympathomimetics Central Nervous System Stimulants Marijuana Abuse Pharmacologic Actions Tetrahydrocannabinol Methamphetamine Analgesics, Non-Narcotic Autonomic Agents Dextroamphetamine Amphetamine Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |