Marijuana Drug Discrimination and Self-Administration (DDC)
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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: | Observational Model: Case-Only Time Perspective: 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: | December 2013 |
| Primary Completion Date: | December 2012 (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.
|
Detailed Description:
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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| Principal Investigator: | Leslie Lundahl, PhD | Wayne State University |
More Information
No publications provided
| Responsible Party: | Leslie Lundahl, Principal Investigator, Wayne State University |
| ClinicalTrials.gov Identifier: | NCT00943930 History of Changes |
| Other Study ID Numbers: | NIDA DA026761, R01DA026761-01 |
| Study First Received: | July 21, 2009 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders Amphetamine Dextroamphetamine Tetrahydrocannabinol Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Hallucinogens Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013