Opioid and Cannabinoid Interactions

Phase 1

Completed

• Conditions: Opioid Use; Marijuana Usage
• Interventions: Drug: Vaporized Marijuana; Drug: Opioid Agonist; Drug: Placebo

• Registration Number: NCT03705559
• Lead Sponsor: Shanna Babalonis, PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2019-06-21
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Results First Submitted: 2025-02-05
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Results First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vaporized Marijuana	Vaporized Marijuana	Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.
Opioid Agonist/Marijuana Combination	Opioid Agonist	Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana 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.
Vaporized Marijuana	Placebo	Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.
Opioid Agonist	Opioid Agonist	Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).
Placebo	Placebo	Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Opioid Agonist	Placebo	Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).
Opioid Agonist/Marijuana Combination	Vaporized Marijuana	Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana 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.

Primary Outcome Measures

Name	Time	Method
Change in Subject-Rated Outcome - VAS Drug Liking	This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.	Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.

Secondary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure	Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.	Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.
Change in Oxygen Saturation	Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.	Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.
Change in Respiration Rate	Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.	Respiration rate (number of breaths per minute). Raw data transformed to trough scores.
Change in Systolic Blood Pressure	Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.	Systolic blood pressure (mm Hg). Raw data transformed to peak scores.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States