Cannabis and Opioid Use Disorder

NCT ID: NCT05729932

Last Updated: 2025-12-15

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2027-06-30

Brief Summary

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This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intranasal Opioid Agonist

Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting).

Group Type EXPERIMENTAL

Inhaled vaporized cannabis

Intervention Type DRUG

Double-blind cannabis and placebo doses, administered through vaporizer

Intransal opioid

Intervention Type DRUG

Double-blind opioid and placebo doses, administered intranasal route

Vaporized cannabis

Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer.

Group Type EXPERIMENTAL

Inhaled vaporized cannabis

Intervention Type DRUG

Double-blind cannabis and placebo doses, administered through vaporizer

Intransal opioid

Intervention Type DRUG

Double-blind opioid and placebo doses, administered intranasal route

Interventions

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Inhaled vaporized cannabis

Double-blind cannabis and placebo doses, administered through vaporizer

Intervention Type DRUG

Intransal opioid

Double-blind opioid and placebo doses, administered intranasal route

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current opioid use disorder

Exclusion Criteria

* Current medical conditions that require medical management
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Shanna Babalonis, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shanna Babalonis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Center on Drug and Alcohol Research

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Nuzzo, MA

Role: CONTACT

859-323-0002

Facility Contacts

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Paul Nuzzo, MA

Role: primary

859-323-0002

Other Identifiers

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1R01DA054347

Identifier Type: NIH

Identifier Source: secondary_id

View Link

75562-20242

Identifier Type: -

Identifier Source: org_study_id

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