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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

Tracking Information
First Submitted Date July 21, 2009
First Posted Date July 22, 2009
Last Update Posted Date April 28, 2016
Study Start Date April 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2016)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00943930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 26, 2016)
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. ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Marijuana Drug Discrimination and Self-Administration
Official Title Smoked Marijuana Discrimination and Marijuana Choice in Humans: A Laboratory Mode
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Marijuana dependent volunteers
Condition Marijuana Abuse
Intervention 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.
Study Groups/Cohorts Marijuana-dependent volunteers
Intervention: Drug: THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2015)
29
Original Estimated Enrollment
 (submitted: July 21, 2009)
25
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00943930
Other Study ID Numbers NIDA DA026761
R01DA026761-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Leslie Lundahl, Wayne State University
Study Sponsor Wayne State University
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Leslie Lundahl, PhD Wayne State University
PRS Account Wayne State University
Verification Date April 2016