Behavioral Economic Analysis of Demand for Marijuana

February 7, 2024 updated by: Elizabeth Aston, Brown University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High THC dose (6% THC)
Smoked marijuana cigarettes (High THC dose [6% THC])
Drug: Smoked marijuana cigarettes: High THC dose (6% THC)
Smoked marijuana cigarettes (High THC dose [6% THC])

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validity of the Marijuana Purchase Task (MPT)
Time Frame: Duration of the experimental session (i.e., 60 minutes)
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. Hits purchased on the MPT will correspond with actual number of hits purchased and smoked in the laboratory. Primary outcome is percentage of participants who purchased and smoked exactly what they said they would.
Duration of the experimental session (i.e., 60 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Subjective marijuana craving was assessed via a 10-item Marijuana Craving Questionnaire. Participants were asked to respond to items according to how they were thinking or feeling "right now," and MCQ items were rated on a 1 = "strongly disagree" to 7 = "strongly agree" scale, with higher scores indicating greater subjective marijuana craving, and summed to yield a total craving score. Total craving score was used in analyses.
The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours
Marijuana Smoking Topography
Time Frame: Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.
Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The outcome measure is number of puffs.
Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Aston, PhD, Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #1502001185

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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