Opioid and Cannabinoid Interactions

Study Overview
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Brief Summary
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This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Official Title
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Interactions of Marijuana and Opioids: Pharmacodynamic Effects

Conditions
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Marijuana Usage, Opioid Use

Intervention / Treatment
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* Drug: Vaporized Marijuana
* Drug: Opioid Agonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults ages 18-50 Current non-medical use of opioids and marijuana Exclusion Criteria: Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics Seeking treatment for drug use Significant medical problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaporized Marijuana<br>Participants will receive non-therapeutic, experimental doses of active or placebo. vaporized marijuana. Active marijuana/placebo will be administered once per session and will be administered via a vaporizer. | Drug: Vaporized Marijuana<br>* Active Marijuana or Placebo, administered through vaporizer<br>* Other names: Cannabis;|
| Experimental: Opioid Agonist<br>Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intranasally (snorting). | Drug: Opioid Agonist<br>* Active Opioid Agonist or Placebo, administered intranasally<br>|
| Experimental: Opioid Agonist/Marijuana Combination<br>Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with non-therapeutic, experimental doses of active vaporized marijuana/placebo. Opioid/placebo and marijuana/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. | Drug: Vaporized Marijuana<br>* Active Marijuana or Placebo, administered through vaporizer<br>* Other names: Cannabis;Drug: Opioid Agonist<br>* Active Opioid Agonist or Placebo, administered intranasally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subject-Rated Outcomes | Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales. | These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oxygen Saturation | Oxygen saturation (measured as a percentage) will be monitored throughout each session. | Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). | 
| Change in Respiration Rate | Respiration rate (number of breaths per minute) | Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). | 
| Change in Blood pressure | Systolic and diastolic blood pressure (mm Hg) | Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marijuana, opioid, opiate, cannabis