Marijuana Drug Discrimination and Self-Administration (DDC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University
ClinicalTrials.gov Identifier:
NCT00943930
First received: July 21, 2009
Last updated: March 20, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Estimated Enrollment: 25
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
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
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943930

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
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: March 20, 2014
Health Authority: United States: Federal Government

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
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
Hormones

ClinicalTrials.gov processed this record on August 28, 2014