Reinforcing Effects of Marijuana and Opioids

Sponsor

Shanna Babalonis, PhD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485012

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Use Opioid Use	Drug: Marijuana Drug: Opioid	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double-blind marijuana/placebo administration Participants will receive double-blind administration of vaporized marijuana/placebo	Drug: Marijuana Double-blind administration of marijuana Other Names: Cannabis Drug: Opioid Double-blind administration of an opioid agonist
Experimental: Double-blind opioid/placebo administration Participants will receive double-blind administration of intranasal opioid agonist/placebo	Drug: Marijuana Double-blind administration of marijuana Other Names: Cannabis Drug: Opioid Double-blind administration of an opioid agonist

Arm

Intervention/Treatment

Experimental: Double-blind marijuana/placebo administration

Participants will receive double-blind administration of vaporized marijuana/placebo

Drug: Marijuana

Double-blind administration of marijuana

Other Names:

Cannabis

Drug: Opioid

Double-blind administration of an opioid agonist

Experimental: Double-blind opioid/placebo administration

Participants will receive double-blind administration of intranasal opioid agonist/placebo

Drug: Marijuana

Double-blind administration of marijuana

Other Names:

Cannabis

Drug: Opioid

Double-blind administration of an opioid agonist

Outcome Measures

Primary Outcome Measures

Self-Administration [Collected once during each self-administration session]
The number of units of drug earned in each session

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,