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Marijuana Drug Discrimination and Self-Administration (DDC)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), December 2009
First Received: July 21, 2009   Last Updated: December 3, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Biospecimen Retention:   None Retained

Biospecimen Description:

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.

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

Contacts
Contact: Lisa Sulkowski (313) 993-3966 lsulkows@med.wayne.edu
Contact: Ken Bates (313) 993-3960 kbates@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48207
Contact: Leslie Lundahl, PhD     313-993-1374     llundahl@med.wayne.edu    
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Leslie Lundahl, PhD Wayne State University
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010