Pain ThresholdPhase 2NCT00743119
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
A Phase 2 study testing Inactive marijuana (0% THC), Low dose Dronabinol and High dose Dronabinol in people with Pain Threshold and Mood, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold, Mood
- What is being tested?
- Inactive marijuana (0% THC), Low dose Dronabinol and High dose Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2013
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between the ages of 21-45
- Current marijuana use
- Able to perform study procedures
- Women practicing an effective form of birth control
Who cannot join
- Female subjects who are currently pregnant or breastfeeding
- Current,repeated illicit drug use other than marijuana
- Presence of significant medical illness
- History of heart disease
- Request for drug treatment
- Current parole or probation
- Recent history of significant violent behavior
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.
Read the detailed description
Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.
- Conditions
- Pain Threshold, Mood
- Being tested
- Placebo capsules, Inactive marijuana (0% THC), Low dose Dronabinol, High dose Dronabinol, Low THC marijuana
- Keywords
- oral thc, cannabis, pain, analgesic effects, dronabinol
- Medical subject headings
- Marijuana Abuse, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo capsulesDrug
Placebo capsules
Inactive marijuana (0% THC)Drug
Inactive marijuana cigarettes (0% THC) provided by NIDA
Low dose DronabinolDrug
Dronabinol 10mg
High dose DronabinolDrug
Dronabinol 20mg
Low THC marijuanaDrug
marijuana cigarettes (1.98% THC) provided by NIDA
High THC marijuanaDrug
Marijuana cigarettes (3.56% THC) provided by NIDA
| Study group | Role | What they receive |
|---|---|---|
| Placebo + inactive marijuana (0% THC) | Placebo comparator | Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. Receives: Drug: Placebo capsules; Drug: Inactive marijuana (0% THC) |
| Dronabinol 10 mg + Marijuana (0% THC) | Experimental | Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. Receives: Drug: Inactive marijuana (0% THC); Drug: Low dose Dronabinol |
| Dronabinol 20 mg + Marijuana (0% THC) | Experimental | Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. Receives: Drug: Inactive marijuana (0% THC); Drug: High dose Dronabinol |
| Placebo + Marijuana (1.98% THC) | Experimental | Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order. Receives: Drug: Placebo capsules; Drug: Low THC marijuana |
| Placebo + Marijuana (3.56% THC) | Experimental | Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order. Receives: Drug: Placebo capsules; Drug: High THC marijuana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance
Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).
Measured: Within each session lasting approximately 5 minutes, for a total of five sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionMay 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ThresholdStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Margaret Haney, Ph.D, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743119
- Sponsor's protocol ID
- 5603
- Other IDs
- 5P50DA009236
- Status last verified
- Nov 2017
- First submitted
- 26 Aug 2008
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper ZD, Comer SD, Haney M. Comparison of the analgesic effects of dronabinol and smoked marijuana in daily marijuana smokers. Neuropsychopharmacology. 2013 Sep;38(10):1984-92. doi: 10.1038/npp.2013.97. Epub 2013 Apr 22.
PubMed 23609132
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
- ClinicalTrials.gov ID
- NCT00743119
- Acronym / sponsor ID
- 5603
- Conditions
- Pain Threshold, Mood
- Keywords
- oral thc, cannabis, pain, analgesic effects, dronabinol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Posted 11 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.
Detailed description
Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo + inactive marijuana (0% THC) | Placebo comparator | Drug: Placebo capsules, Drug: Inactive marijuana (0% THC)Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. |
| Dronabinol 10 mg + Marijuana (0% THC) | Experimental | Drug: Inactive marijuana (0% THC), Drug: Low dose DronabinolParticipants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. |
| Dronabinol 20 mg + Marijuana (0% THC) | Experimental | Drug: Inactive marijuana (0% THC), Drug: High dose DronabinolParticipants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order. |
| Placebo + Marijuana (1.98% THC) | Experimental | Drug: Placebo capsules, Drug: Low THC marijuanaParticipants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order. |
| Placebo + Marijuana (3.56% THC) | Experimental | Drug: Placebo capsules, Drug: High THC marijuanaParticipants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults between the ages of 21-45
- Current marijuana use
- Able to perform study procedures
- Women practicing an effective form of birth control
Key exclusion criteria (7 listed)
- Female subjects who are currently pregnant or breastfeeding
- Current,repeated illicit drug use other than marijuana
- Presence of significant medical illness
- History of heart disease
- Request for drug treatment
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 |
|---|---|---|
| Placebo capsulesPlacebo capsules | Drug | Placebo + Marijuana (1.98% THC), Placebo + Marijuana (3.56% THC), Placebo + inactive marijuana (0% THC) |
| Inactive marijuana (0% THC)Inactive marijuana cigarettes (0% THC) provided by NIDA | Drug | Dronabinol 10 mg + Marijuana (0% THC), Dronabinol 20 mg + Marijuana (0% THC), Placebo + inactive marijuana (0% THC) |
| Low dose DronabinolDronabinol 10mg | Drug | Dronabinol 10 mg + Marijuana (0% THC) |
| High dose DronabinolDronabinol 20mg | Drug | Dronabinol 20 mg + Marijuana (0% THC) |
| Low THC marijuanamarijuana cigarettes (1.98% THC) provided by NIDA | Drug | Placebo + Marijuana (1.98% THC) |
| High THC marijuanaMarijuana cigarettes (3.56% THC) provided by NIDA | Drug | Placebo + Marijuana (3.56% THC) |
Primary outcome
Pain Tolerance
Time frame: Within each session lasting approximately 5 minutes, for a total of five sessions
Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23609132Cooper ZD, Comer SD, Haney M. Comparison of the analgesic effects of dronabinol and smoked marijuana in daily marijuana smokers. Neuropsychopharmacology. 2013 Sep;38(10):1984-92. doi: 10.1038/npp.2013.97. Epub 2013 Apr 22.
- Individual participant dataSharing planned: No
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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.
Margaret Haney, Ph.D principal investigator
New York State Psychiatric Institute
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 Inactive marijuana (0% THC), Low dose Dronabinol and High dose Dronabinol in people with Pain Threshold and Mood, run by New York State Psychiatric Institute 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 4 inclusion and 7 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 11 Dec 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. Some participants in this study may receive a placebo. 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 11 Dec 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?
Pain Tolerance (time frame: Within each session lasting approximately 5 minutes, for a total of five sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743119, which also lists 1 linked publication.
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 11 Dec 2017.