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Cannabis and Opioid Use Disorder

Primary Purpose

Opioid Use Disorder

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Inhaled vaporized cannabis

Intransal opioid

About this trial

This is an interventional basic science trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Current opioid use disorder Exclusion Criteria: Current medical conditions that require medical management

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intranasal Opioid Agonist

Vaporized cannabis

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)

Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)

Secondary Outcome Measures

Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)

Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)

Change from Baseline - Respiration

Physiological monitoring of respiration rate (breaths per minute)

Full Information

NCT ID

NCT05729932

First Posted

January 13, 2023

Last Updated

July 6, 2023

Sponsor

University of Kentucky

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05729932

Brief Title

Cannabis and Opioid Use Disorder

Official Title

Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kentucky

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intranasal Opioid Agonist

Arm Type

Experimental

Arm Description

Arm Title

Vaporized cannabis

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Inhaled vaporized cannabis

Intervention Description

Double-blind cannabis and placebo doses, administered through vaporizer

Intervention Type

Drug

Intervention Name(s)

Intransal opioid

Intervention Description

Double-blind opioid and placebo doses, administered intranasal route

Primary Outcome Measure Information:

Title

Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)

Description

Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)

Time Frame

Change from baseline

Secondary Outcome Measure Information:

Title

Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)

Description

Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)

Time Frame

Change from baseline

Title

Change from Baseline - Respiration

Description

Physiological monitoring of respiration rate (breaths per minute)

Time Frame

Change from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current opioid use disorder Exclusion Criteria: Current medical conditions that require medical management

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Nuzzo, MA

Phone

859-323-0002

pnuzz2@email.uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shanna Babalonis, PhD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cannabis and Opioid Use Disorder

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