Marijuana SmokingPhase 1/2NCT01394185
Effects of Dronabinol (Oral THC) on Cannabis Use
A Phase 1/2 study testing Dronabinol 120mg/day and Dronabinol 240mg/day in people with Marijuana Smoking, run by Johns Hopkins University at 1 site in United States.
Trial summary
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Smoking
- What is being tested?
- Dronabinol 120mg/day and Dronabinol 240mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 1/2
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current use of marijuana
- Able to give informed consent
Who cannot join
- Daily use of psychoactive medication
- Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
- Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
- Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
- Uncontrolled or unstable cardiovascular disease
- Allergy to sesame oil
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University (Bayview Campus)
Baltimore, Maryland, 21224
About this study
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.
- Conditions
- Marijuana Smoking
- Being tested
- Dronabinol 120mg/day, Placebo, Dronabinol 240mg/day
- Keywords
- marijuana, dronabinol, pharmacotherapy
- Medical subject headings
- Marijuana Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol 120mg/dayDrug
Also called Marinol, THC
Participants receive 40mg dronabinol 3 times daily
PlaceboDrug
Participants receive placebo
Dronabinol 240mg/dayDrug
Also called Marinol, THC
Participants receive 80mg dronabinol 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Dronabinol, High Dose Dronabinol, and placebo | Active comparator | Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order Receives: Drug: Dronabinol 120mg/day; Drug: Placebo; Drug: Dronabinol 240mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Self-administration - Progressive Ratio
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint
Measured: 12-day Dronabinol maintenance period
Marijuana Self-administration - Drug Vs Money Choice
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint
Measured: 12-day Dronabinol maintenance period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
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 Johns Hopkins 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan Vandrey, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394185
- Sponsor's protocol ID
- NA_00041251
- Other IDs
- R01DA025044
- Status last verified
- Aug 2017
- First submitted
- 12 Jul 2011
- Last updated
- 3 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dronabinol (Oral THC) on Cannabis Use
- ClinicalTrials.gov ID
- NCT01394185
- Acronym / sponsor ID
- NA_00041251
- Conditions
- Marijuana Smoking
- Keywords
- marijuana, dronabinol, pharmacotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Posted 3 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose Dronabinol, High Dose Dronabinol, and placebo | Active comparator | Drug: Dronabinol 120mg/day, Drug: Placebo, Drug: Dronabinol 240mg/dayParticipants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current use of marijuana
- Able to give informed consent
Key exclusion criteria (6 listed)
- Daily use of psychoactive medication
- Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
- Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
- Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
- Uncontrolled or unstable cardiovascular disease
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 |
|---|---|---|
| Dronabinol 120mg/dayAlso: Marinol, THCParticipants receive 40mg dronabinol 3 times daily | Drug | Low Dose Dronabinol, High Dose Dronabinol, and placebo |
| PlaceboParticipants receive placebo | Drug | Low Dose Dronabinol, High Dose Dronabinol, and placebo |
| Dronabinol 240mg/dayAlso: Marinol, THCParticipants receive 80mg dronabinol 3 times daily | Drug | Low Dose Dronabinol, High Dose Dronabinol, and placebo |
Primary outcome
Marijuana Self-administration - Progressive Ratio
Time frame: 12-day Dronabinol maintenance period
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint
Marijuana Self-administration - Drug Vs Money Choice
Time frame: 12-day Dronabinol maintenance period
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- 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.
Ryan Vandrey, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dronabinol 120mg/day and Dronabinol 240mg/day in people with Marijuana Smoking, run by Johns Hopkins 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 2 inclusion and 6 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 3 Aug 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 3 Aug 2017). 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?
Marijuana Self-administration - Progressive Ratio (time frame: 12-day Dronabinol maintenance period). The study lists 2 primary outcomes in all. 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 3 Aug 2017.