NCT03518567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2021

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 12, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

April 9, 2018

Results QC Date

January 8, 2024

Last Update Submit

February 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validity of the Marijuana Purchase Task (MPT)

    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 Outcomes (2)

  • Change in Marijuana Craving Questionnaire (MCQ)

    The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours

  • Marijuana Smoking Topography

    Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.

Study Arms (1)

High THC dose (6% THC)

EXPERIMENTAL

Smoked marijuana cigarettes (High THC dose \[6% THC\])

Drug: Smoked marijuana cigarettes: High THC dose (6% THC)

Interventions

Smoked marijuana cigarettes (High THC dose \[6% THC\])

High THC dose (6% THC)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Marijuana Smoking

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Marijuana UseBehaviorSmoking, Non-Tobacco ProductsSmoking

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Elizabeth Aston, PhD
Organization
Brown University

Study Officials

  • Elizabeth Aston, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 8, 2018

Study Start

October 15, 2018

Primary Completion

May 24, 2021

Study Completion

May 24, 2021

Last Updated

February 12, 2024

Results First Posted

February 12, 2024

Record last verified: 2024-02

Locations