Marijuana SmokingPhase 2NCT03518567
Behavioral Economic Analysis of Demand for Marijuana
A Phase 2 study testing Smoked marijuana cigarettes: High THC dose (6% THC) in people with Marijuana Smoking, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Smoking
- What is being tested?
- Smoked marijuana cigarettes: High THC dose (6% THC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 24 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Marijuana Smoking
- Being tested
- Smoked marijuana cigarettes: High THC dose (6% THC)
- Medical subject headings
- Marijuana Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked marijuana cigarettes: High THC dose (6% THC)Drug
Smoked marijuana cigarettes (High THC dose [6% THC])
| Study group | Role | What they receive |
|---|---|---|
| High THC dose (6% THC) | Experimental | Smoked marijuana cigarettes (High THC dose [6% THC]) Receives: Drug: Smoked marijuana cigarettes: High THC dose (6% THC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of the experimental session (i.e., 60 minutes)
Secondary outcomes (2)
Change in Marijuana Craving Questionnaire (MCQ)
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.
Measured: The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours
Marijuana Smoking Topography
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.
Measured: Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start15 Oct 2018
- Primary completion24 May 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana SmokingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Aston, Brown University
- Investigators
- Elizabeth Aston, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518567
- Sponsor's protocol ID
- #1502001185
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2018
- Last updated
- 12 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Analysis of Demand for Marijuana
- ClinicalTrials.gov ID
- NCT03518567
- Acronym / sponsor ID
- #1502001185
- Conditions
- Marijuana Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Posted 12 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High THC dose (6% THC) | Experimental | Drug: Smoked marijuana cigarettes: High THC dose (6% THC)Smoked marijuana cigarettes (High THC dose [6% THC]) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- positive pregnancy test
- nursing
- inability to use contraception during the study
- poor physical health
- positive breath alcohol concentration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoked marijuana cigarettes: High THC dose (6% THC)Smoked marijuana cigarettes (High THC dose [6% THC]) | Drug | High THC dose (6% THC) |
Primary outcome
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.
2 secondary outcomes
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
Marijuana Smoking Topography
Time frame: Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Aston, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Smoked marijuana cigarettes: High THC dose (6% THC) in people with Marijuana Smoking, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the Marijuana Purchase Task (MPT) (time frame: Duration of the experimental session (i.e., 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.