Reinforcing Effects of Marijuana and Opioids

Phase 1

Recruiting

• Conditions: Opioid Use; Marijuana Use
• Interventions: Drug: Marijuana; Drug: Opioid

• Registration Number: NCT05485012
• Lead Sponsor: Shanna Babalonis, PhD

Brief Summary

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-02
• Study Start: 2023-08-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Ages 18-50
• Experience with marijuana and opioids
• General good health
• Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,

Exclusion Criteria

• Significant medical complications/conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Double-blind marijuana/placebo administration	Opioid	Participants will receive double-blind administration of vaporized marijuana/placebo
Double-blind opioid/placebo administration	Opioid	Participants will receive double-blind administration of intranasal opioid agonist/placebo
Double-blind marijuana/placebo administration	Marijuana	Participants will receive double-blind administration of vaporized marijuana/placebo
Double-blind opioid/placebo administration	Marijuana	Participants will receive double-blind administration of intranasal opioid agonist/placebo

Primary Outcome Measures

Name	Time	Method
Self-Administration	Collected once during each self-administration session	The number of units of drug earned in each session

Secondary Outcome Measures

Name	Time	Method
Subjective measures	Baseline, post-dose during each session (change from baseline is assessed); visual analog scales will be the primary measure (0-100, 0=not at all, 100=extremely)	Ratings of drug effects (e.g., feeling high, impaired, good drug effects)
Heart rate	Baseline, post-dose during each session (change from baseline is assessed)	Beats per minute
Blood pressure	Baseline, post-dose during each session (change from baseline is assessed)	Systolic and diastolic blood pressure (mm/hg)

Trial Locations

Locations (1)

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