Reinforcing Effects of Marijuana and Opioids

NCT ID: NCT05485012

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-03

Study Completion Date

2025-03-27

Brief Summary

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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

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Conditions

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Marijuana Use Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Double-blind marijuana/placebo administration

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

Group Type EXPERIMENTAL

Marijuana

Intervention Type DRUG

Double-blind administration of marijuana

Opioid

Intervention Type DRUG

Double-blind administration of an opioid agonist

Double-blind opioid/placebo administration

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

Group Type EXPERIMENTAL

Marijuana

Intervention Type DRUG

Double-blind administration of marijuana

Opioid

Intervention Type DRUG

Double-blind administration of an opioid agonist

Interventions

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Marijuana

Double-blind administration of marijuana

Intervention Type DRUG

Opioid

Double-blind administration of an opioid agonist

Intervention Type DRUG

Other Intervention Names

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Cannabis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Shanna Babalonis, PhD

OTHER

Sponsor Role lead

Responsible Party

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Shanna Babalonis, PhD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shanna Babalonis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DA045700

Identifier Type: NIH

Identifier Source: secondary_id

View Link

45017-20221

Identifier Type: -

Identifier Source: org_study_id

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