NCT05485012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

July 18, 2022

Results QC Date

March 4, 2026

Last Update Submit

April 12, 2026

Conditions

Marijuana UseOpioid Use

Keywords

marijuanaopioidhealthy participantslaboratory study

Outcome Measures

Primary Outcomes (1)

  • Self-Administration of Drug Units Earned

    The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM).

    Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session

Secondary Outcomes (2)

  • Peak End-tidal Carbon Dioxide (EtCO2)

    This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).

  • Trough Respiration Rate

    This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).

Study Arms (2)

Double-blind marijuana/placebo administration

EXPERIMENTAL

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

Drug: MarijuanaDrug: Opioid

Double-blind opioid/placebo administration

EXPERIMENTAL

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

Drug: MarijuanaDrug: Opioid

Interventions

MarijuanaDRUG

Double-blind administration of marijuana

Also known as: Cannabis
Double-blind marijuana/placebo administrationDouble-blind opioid/placebo administration
OpioidDRUG

Double-blind administration of an opioid agonist

Double-blind marijuana/placebo administrationDouble-blind opioid/placebo administration

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • Significant medical complications/conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Marijuana UseMarijuana Abuse

Interventions

nabiximolsAnalgesics, Opioid

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Results Point of Contact

Title
Shanna Babalonis, Ph.D.
Organization
University of Kentucky
babalonis@uky.edu
859-257-1881

Study Officials

  • Shanna Babalonis, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

August 2, 2022

Study Start

August 3, 2023

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

April 15, 2026

Results First Posted

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)