PainPhase 1NCT03679949
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
A Phase 1 study testing Oxycodone, Cannabis (THC:CBD = ~ 1:0) and Cannabis (THC:CBD = ~ 0:1) in people with Pain and Abuse, Drug, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic. Read more about this study
- Who is it for?
- Ages 21 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Abuse, Drug
- What is being tested?
- Oxycodone, Cannabis (THC:CBD = ~ 1:0) and Cannabis (THC:CBD = ~ 0:1)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 6 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female aged 21-53 years
- Previous cannabis use
- Previous opioid use
- Urine test positive for recent cannabis use
- Being able to perform all study procedures
- Currently practicing an effective form of birth control (women only)
Who cannot join
- Meeting criteria for some Use Disorders
- Report regular illicit drug use
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness
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 purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.
- Conditions
- Pain, Abuse, Drug
- Being tested
- Oxycodone, Cannabis (THC:CBD = ~ 1:0), Cannabis (THC:CBD = ~ 0:1), Cannabis (THC:CBD = ~ 1:1), Placebo
- Keywords
- experimental pain, Cannabis, Cannabidiol, THC
- Medical subject headings
- Pain, Substance-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Oxycodone, 2.5 mg
Cannabis (THC:CBD = ~ 1:0)Drug
Cannabis with high THC concentration and negligible CBD concentrations
Cannabis (THC:CBD = ~ 0:1)Drug
Cannabis with high CBD concentration and negligible THC concentrations
Cannabis (THC:CBD = ~ 1:1)Drug
Cannabis with equivalent CBD and THC concentrations
PlaceboDrug
Also called Placebo cannabis
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized) Receives: Drug: Placebo |
| Oxycodone | Experimental | Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized) Receives: Drug: Oxycodone; Drug: Placebo |
| Cannabis (THC:CBD = ~1:0) | Experimental | Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized) Receives: Drug: Cannabis (THC:CBD = ~ 1:0); Drug: Placebo |
| Cannabis (THC:CBD = ~ 0:1) | Experimental | Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized) Receives: Drug: Cannabis (THC:CBD = ~ 0:1); Drug: Placebo |
| Cannabis (THC:CBD = ~ 1:1) | Experimental | Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized) Receives: Drug: Cannabis (THC:CBD = ~ 1:1); Drug: Placebo |
| Cannabis (THC:CBD = ~1:0) + Oxycodone | Experimental | Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized) Receives: Drug: Oxycodone; Drug: Cannabis (THC:CBD = ~ 1:0) |
| Cannabis (THC:CBD = ~ 0:1) + Oxycodone | Experimental | Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized) Receives: Drug: Oxycodone; Drug: Cannabis (THC:CBD = ~ 0:1) |
| Cannabis (THC:CBD = ~ 1:1) + Oxycodone | Experimental | Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized) Receives: Drug: Oxycodone; Drug: Cannabis (THC:CBD = ~ 1:1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Effects
Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).
Measured: 6 weeks
Cold Pressor Test
Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Apr 2019
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline A. Arout, Ph.D., New York State Psychiatric Institute
- Investigators
- Caroline A Cooper, PhD, Principal investigator, New York Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679949
- Sponsor's protocol ID
- 7647
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2018
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
- ClinicalTrials.gov ID
- NCT03679949
- Acronym / sponsor ID
- 7647
- Conditions
- Pain, Abuse, Drug
- Keywords
- experimental pain, Cannabis, Cannabidiol, THC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized) |
| Oxycodone | Experimental | Drug: Oxycodone, Drug: PlaceboParticipants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized) |
| Cannabis (THC:CBD = ~1:0) | Experimental | Drug: Cannabis (THC:CBD = ~ 1:0), Drug: PlaceboParticipants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized) |
| Cannabis (THC:CBD = ~ 0:1) | Experimental | Drug: Cannabis (THC:CBD = ~ 0:1), Drug: PlaceboParticipants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized) |
| Cannabis (THC:CBD = ~ 1:1) | Experimental | Drug: Cannabis (THC:CBD = ~ 1:1), Drug: PlaceboParticipants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized) |
| Cannabis (THC:CBD = ~1:0) + Oxycodone | Experimental | Drug: Oxycodone, Drug: Cannabis (THC:CBD = ~ 1:0)Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized) |
| Cannabis (THC:CBD = ~ 0:1) + Oxycodone | Experimental | Drug: Oxycodone, Drug: Cannabis (THC:CBD = ~ 0:1)Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized) |
| Cannabis (THC:CBD = ~ 1:1) + Oxycodone | Experimental | Drug: Oxycodone, Drug: Cannabis (THC:CBD = ~ 1:1)Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized) |
Who may qualify
- Ages
- 21 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or non-pregnant female aged 21-53 years
- Previous cannabis use
- Previous opioid use
- Urine test positive for recent cannabis use
- Being able to perform all study procedures
Key exclusion criteria (3 listed)
- Meeting criteria for some Use Disorders
- Report regular illicit drug use
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness
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 |
|---|---|---|
| OxycodoneOxycodone, 2.5 mg | Drug | Cannabis (THC:CBD = ~ 0:1) + Oxycodone, Cannabis (THC:CBD = ~ 1:1) + Oxycodone, Cannabis (THC:CBD = ~1:0) + Oxycodone, Oxycodone |
| Cannabis (THC:CBD = ~ 1:0)Cannabis with high THC concentration and negligible CBD concentrations | Drug | Cannabis (THC:CBD = ~1:0), Cannabis (THC:CBD = ~1:0) + Oxycodone |
| Cannabis (THC:CBD = ~ 0:1)Cannabis with high CBD concentration and negligible THC concentrations | Drug | Cannabis (THC:CBD = ~ 0:1), Cannabis (THC:CBD = ~ 0:1) + Oxycodone |
| Cannabis (THC:CBD = ~ 1:1)Cannabis with equivalent CBD and THC concentrations | Drug | Cannabis (THC:CBD = ~ 1:1), Cannabis (THC:CBD = ~ 1:1) + Oxycodone |
| PlaceboAlso: Placebo cannabisCannabis with negligible amounts of THC and CBD 0.0 mg oxycodone | Drug | Cannabis (THC:CBD = ~ 0:1), Cannabis (THC:CBD = ~ 1:1), Cannabis (THC:CBD = ~1:0), Oxycodone, Placebo |
Primary outcome
Subjective Effects
Time frame: 6 weeks
Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).
Cold Pressor Test
Time frame: 6 weeks
Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Caroline A Cooper, PhD principal investigator
New York 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 1 study testing Oxycodone, Cannabis (THC:CBD = ~ 1:0) and Cannabis (THC:CBD = ~ 0:1) in people with Pain and Abuse, Drug, 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 6 inclusion and 3 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 5 Dec 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective Effects (time frame: 6 weeks). 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 5 Dec 2024.