Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03679949 |
Recruitment Status :
Active, not recruiting
First Posted : September 21, 2018
Last Update Posted : December 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Pain Abuse, Drug | Drug: Oxycodone Drug: Cannabis (THC:CBD = ~ 1:0) Drug: Cannabis (THC:CBD = ~ 0:1) Drug: Cannabis (THC:CBD = ~ 1:1) Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention 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 (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | July 1, 2024 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)
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Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Name: Placebo cannabis |
Experimental: Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
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Drug: Oxycodone
Oxycodone, 2.5 mg Drug: Placebo Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Name: Placebo cannabis |
Experimental: Cannabis (THC:CBD = ~1:0)
Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
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Drug: Cannabis (THC:CBD = ~ 1:0)
Cannabis with high THC concentration and negligible CBD concentrations Drug: Placebo Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Name: Placebo cannabis |
Experimental: Cannabis (THC:CBD = ~ 0:1)
Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
|
Drug: Cannabis (THC:CBD = ~ 0:1)
Cannabis with high CBD concentration and negligible THC concentrations Drug: Placebo Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Name: Placebo cannabis |
Experimental: Cannabis (THC:CBD = ~ 1:1)
Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)
|
Drug: Cannabis (THC:CBD = ~ 1:1)
Cannabis with equivalent CBD and THC concentrations Drug: Placebo Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Name: Placebo cannabis |
Experimental: Cannabis (THC:CBD = ~1:0) + Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
|
Drug: Oxycodone
Oxycodone, 2.5 mg Drug: Cannabis (THC:CBD = ~ 1:0) Cannabis with high THC concentration and negligible CBD concentrations |
Experimental: Cannabis (THC:CBD = ~ 0:1) + Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
|
Drug: Oxycodone
Oxycodone, 2.5 mg Drug: Cannabis (THC:CBD = ~ 0:1) Cannabis with high CBD concentration and negligible THC concentrations |
Experimental: Cannabis (THC:CBD = ~ 1:1) + Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)
|
Drug: Oxycodone
Oxycodone, 2.5 mg Drug: Cannabis (THC:CBD = ~ 1:1) Cannabis with equivalent CBD and THC concentrations |
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 53 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679949
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Caroline A Cooper, PhD | New York Psychiatric Institute |
Responsible Party: | Caroline A. Arout, Ph.D., Research Scientist, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT03679949 |
Other Study ID Numbers: |
7647 |
First Posted: | September 21, 2018 Key Record Dates |
Last Update Posted: | December 23, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
experimental pain Cannabis Cannabidiol THC |
Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Oxycodone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |