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OpenTrials
Completed

NCT Number: NCT03705559

Opioid and Cannabinoid Interactions

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.

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Key information

Conditions

Marijuana Usage Chemically-Induced Disorders Marijuana Abuse Mental Disorders Opioid Use Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40508, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaporized Marijuana

Drug

Active Marijuana administered through vaporizer

Other names: Cannabis, THC

Opioid Agonist

Drug

Active Opioid Agonist administered intranasally

Other names: Oxycodone

Placebo

Drug

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

Primary outcomes

  1. Change in Subject-Rated Outcome - VAS Drug Liking

    Time frame: 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.

    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.

Secondary outcomes

  1. Change in Oxygen Saturation

    Time frame: 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.

    Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.

  2. Change in Respiration Rate

    Time frame: 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.

    Respiration rate (number of breaths per minute). Raw data transformed to trough scores.

  3. Change in Systolic Blood Pressure

    Time frame: 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.

    Systolic blood pressure (mm Hg). Raw data transformed to peak scores.

  4. Change in Diastolic Blood Pressure

    Time frame: 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.

    Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.

Sponsors and collaborators

Lead sponsor

Shanna Babalonis, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Interactions of Marijuana and Opioids: Pharmacodynamic Effects

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2018
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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