Reinforcing Effects of Marijuana and Opioids

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485012
• Other study ID #: 45017-20221
• Secondary ID: R01DA045700
• Status: Recruiting
• Phase: Phase 1
• Start date: August 3, 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: Paul Nuzzo
• Phone: (859) 323-0002
• Email: pnuzz2[@]email.uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Use
• Opioid Use

Intervention

Drug:
• Marijuana
Double-blind administration of marijuana
• Opioid
Double-blind administration of an opioid agonist

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Shanna Babalonis, PhD	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Administration	The number of units of drug earned in each session	Collected once during each self-administration session
Secondary	Subjective measures	Ratings of drug effects (e.g., feeling high, impaired, good drug effects)	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)
Secondary	Heart rate	Beats per minute	Baseline, post-dose during each session (change from baseline is assessed)
Secondary	Blood pressure	Systolic and diastolic blood pressure (mm/hg)	Baseline, post-dose during each session (change from baseline is assessed)