Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Conditions
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Pain, Abuse, Drug

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Cannabis (THC:CBD =   1:0)
* Drug: Cannabis (THC:CBD =   0:1)
* Drug: Cannabis (THC:CBD =   1:1)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized) | Drug: Placebo<br>* Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone<br>* Other names: Placebo cannabis;|
| Experimental: Oxycodone<br>Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized) | Drug: Oxycodone<br>* Oxycodone, 2.5 mg<br>Drug: Placebo<br>* Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone<br>* Other names: Placebo cannabis;|
| Experimental: Cannabis (THC:CBD =  1:0)<br>Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized) | Drug: Cannabis (THC:CBD =   1:0)<br>* Cannabis with high THC concentration and negligible CBD concentrations<br>Drug: Placebo<br>* Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone<br>* Other names: Placebo cannabis;|
| Experimental: Cannabis (THC:CBD =   0:1)<br>Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized) | Drug: Cannabis (THC:CBD =   0:1)<br>* Cannabis with high CBD concentration and negligible THC concentrations<br>Drug: Placebo<br>* Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone<br>* Other names: Placebo cannabis;|
| Experimental: Cannabis (THC:CBD =   1:1)<br>Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized) | Drug: Cannabis (THC:CBD =   1:1)<br>* Cannabis with equivalent CBD and THC concentrations<br>Drug: Placebo<br>* Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone<br>* Other names: Placebo cannabis;|
| Experimental: Cannabis (THC:CBD =  1:0) + Oxycodone<br>Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized) | Drug: Oxycodone<br>* Oxycodone, 2.5 mg<br>Drug: Cannabis (THC:CBD =   1:0)<br>* Cannabis with high THC concentration and negligible CBD concentrations<br>|
| Experimental: Cannabis (THC:CBD =   0:1) + Oxycodone<br>Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized) | Drug: Oxycodone<br>* Oxycodone, 2.5 mg<br>Drug: Cannabis (THC:CBD =   0:1)<br>* Cannabis with high CBD concentration and negligible THC concentrations<br>|
| Experimental: Cannabis (THC:CBD =   1:1) + Oxycodone<br>Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized) | Drug: Oxycodone<br>* Oxycodone, 2.5 mg<br>Drug: Cannabis (THC:CBD =   1:1)<br>* Cannabis with equivalent CBD and THC concentrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Effects | Participants will rate drug liking, good drug effects, and high on a visual analogue scale (VAS; 1-100mm). | 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). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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experimental pain, Cannabis, Cannabidiol, THC