Opioid and Cannabinoid Interactions

NCT ID: NCT03705559

Last Updated: 2025-04-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-21

Study Completion Date

2024-02-15

Brief Summary

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This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Detailed Description

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Conditions

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Marijuana Usage Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
This is a randomized, double-blind, double-dummy, placebo-controlled design

Study Groups

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Vaporized Marijuana

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

Group Type EXPERIMENTAL

Vaporized Marijuana

Intervention Type DRUG

Active Marijuana administered through vaporizer

Placebo

Intervention Type DRUG

Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Opioid Agonist

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

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Active Opioid Agonist administered intranasally

Placebo

Intervention Type DRUG

Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Opioid Agonist/Marijuana Combination

Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.

Group Type EXPERIMENTAL

Vaporized Marijuana

Intervention Type DRUG

Active Marijuana administered through vaporizer

Opioid Agonist

Intervention Type DRUG

Active Opioid Agonist administered intranasally

Placebo

Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Interventions

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Vaporized Marijuana

Active Marijuana administered through vaporizer

Intervention Type DRUG

Opioid Agonist

Active Opioid Agonist administered intranasally

Intervention Type DRUG

Placebo

Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Intervention Type DRUG

Other Intervention Names

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Cannabis THC Oxycodone

Eligibility Criteria

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Inclusion Criteria

* Healthy adults ages 18-50
* Current non-medical use of opioids and marijuana

Exclusion Criteria

* Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
* Seeking treatment for drug use
* Significant medical problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Principal Investigator

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: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R01DA045700

Identifier Type: NIH

Identifier Source: secondary_id

View Link

45017

Identifier Type: -

Identifier Source: org_study_id

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