Opioid and Cannabinoid Interactions

NCT03705559 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 45017R01DA045700
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Marijuana Usage; Opioid Use

Keywords

marijuana; opioid; opiate; cannabis

Outcome Measures

Primary Outcomes (1)

• Change in Subject-Rated Outcome - VAS Drug Liking

  Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.

  This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

Secondary Outcomes (4)

• Change in Oxygen Saturation

  Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.

• Change in Respiration Rate

  Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.

• Change in Systolic Blood Pressure

  Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

• Change in Diastolic Blood Pressure

  Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

Study Arms (4)

Vaporized Marijuana

EXPERIMENTAL

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.

Drug: Vaporized Marijuana; Drug: Placebo

Opioid Agonist

EXPERIMENTAL

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).

Drug: Opioid Agonist; Drug: Placebo

Opioid Agonist/Marijuana Combination

EXPERIMENTAL

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.

Drug: Vaporized Marijuana; Drug: Opioid Agonist

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vaporized Marijuana DRUG

Active Marijuana administered through vaporizer

Also known as: Cannabis, THC

Opioid Agonist/Marijuana Combination; Vaporized Marijuana

Opioid Agonist DRUG

Active Opioid Agonist administered intranasally

Also known as: Oxycodone

Opioid Agonist; Opioid Agonist/Marijuana Combination

Placebo DRUG

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

Opioid Agonist; Placebo; Vaporized Marijuana

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
• Seeking treatment for drug use
• Significant medical problems

Sponsors & Collaborators

• Shanna Babalonis, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols; Dronabinol; Analgesics, Opioid; Oxycodone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a randomized, double-blind, double-dummy, placebo-controlled design
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 15, 2018
• Study Start: June 21, 2019
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)