ClinicalTrials.gov
ClinicalTrials.gov Menu

Marijuana Drug Discrimination and Self-Administration (DDC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00943930
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University

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.

Condition or disease Intervention/treatment
Marijuana Abuse Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC

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.


Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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. [ 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Marijuana dependent volunteers
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Leslie Lundahl, PhD Wayne State University

Responsible Party: Leslie Lundahl, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT00943930     History of Changes
Other Study ID Numbers: NIDA DA026761
R01DA026761-01 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Marijuana Abuse
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Amphetamine
Dextroamphetamine
Dronabinol
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists