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Behavioral Economic Analysis of Demand for Marijuana

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ClinicalTrials.gov Identifier: NCT03518567
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth Aston, Brown University

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
Change in Marijuana Purchase Task (MPT) [ Time Frame: MPT will be administered twice during the experimental session, up to 6 hours: at baseline and pre-smoking ]
The Marijuana Purchase Task will be used to collect data on marijuana demand. Participants indicate how much marijuana they would purchase at varying levels of price (e.g., free - $60). Indices of marijuana demand are derived from the task and used to determine the relative value of marijuana for each participant.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
Change in Marijuana Purchase Task (MPT) [ Time Frame: MPT will be administered 3 times during the experimental session, up to 6 hours: at baseline, pre-marijuana cue-reactivity, and pre-smoking ]
The Marijuana Purchase Task will be used to collect data on marijuana demand. Participants indicate how much marijuana they would purchase at varying levels of price (e.g., free - $60). Indices of marijuana demand are derived from the task and used to determine the relative value of marijuana for each participant.
Change History Complete list of historical versions of study NCT03518567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • Change in Marijuana Craving Questionnaire (MCQ) [ Time Frame: The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours ]
    The Marijuana Craving Questionnaire will be used to collect data on craving for marijuana.
  • Marijuana Smoking Topography [ Time Frame: Marijuana smoking topography indices will be collected during the ad libitum marijuana smoking topography experimental session, up to 6 hours ]
    Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The device tracks number of puffs, puff length, and inter-puff-interval.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
  • Change in Marijuana Craving Questionnaire (MCQ) [ Time Frame: The MCQ will be administered pre- and post- marijuana cue presentation during the experimental session, up to 6 hours ]
    The Marijuana Craving Questionnaire will be used to collect data on craving for marijuana.
  • Marijuana Smoking Topography [ Time Frame: Marijuana smoking topography indices will be collected during the ad libitum marijuana smoking topography experimental session, up to 6 hours ]
    Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The device tracks number of puffs, puff length, and inter-puff-interval.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Economic Analysis of Demand for Marijuana
Official Title  ICMJE Behavioral Economic Analysis of Demand for Marijuana
Brief Summary This laboratory study will employ a multi-session experimental design to examine the behavioral economic demand for marijuana, by studying effect of marijuana administration (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.
Detailed Description This laboratory study will employ a multi-session experimental design to examine craving for marijuana, the effect of marijuana administration (High THC) on behavioral economic demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly. The relationship between hypothetical and actual demand for marijuana will be examined. We will also investigate relationship between demand for marijuana and indices of marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly to obtain a final sample of 85 with complete data (15% of attrition). Participants will be tested at a baseline session and during two experimental sessions (an ad libitum marijuana smoking session and a marijuana smoking topography session). This study will confirm the utility of the hypothetical marijuana purchase task as a reliable and valid tool for assessing behavioral economic marijuana demand.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Marijuana Smoking
Intervention  ICMJE Drug: Smoked marijuana cigarettes: High THC dose (6% THC)
Smoked marijuana cigarettes (High THC dose [6% THC])
Study Arms  ICMJE Experimental: High THC dose (6% THC)
Smoked marijuana cigarettes (High THC dose [6% THC])
Intervention: Drug: Smoked marijuana cigarettes: High THC dose (6% 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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • marijuana use at least 8 times in the past month on average and at least monthly for the past 6 months
  • English-speaking
  • negative urine toxicology screen for drugs other than marijuana
  • non-treatment seeking
  • purchase of marijuana at least twice in the past 6 months to confirm familiarity with the construct to be measured

Exclusion Criteria:

  • positive pregnancy test
  • nursing
  • inability to use contraception during the study
  • poor physical health
  • positive breath alcohol concentration
  • diagnosis of a current affective disorder, psychosis, and panic disorder
  • self-report of past serious adverse reaction to marijuana
  • current psychotropic drug use
  • smoking more than 20 tobacco cigarettes per day
  • inability to abstain from marijuana for 15 hours
  • body mass index outside 18.5-30 kg/m2 range
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elizabeth Aston, PhD 401-863-6668 elizabeth_aston@brown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03518567
Other Study ID Numbers  ICMJE #1502001185
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Aston, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth Aston, PhD Brown University
PRS Account Brown University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP