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OpenTrials
Completed

NCT Number: NCT05485012

Reinforcing Effects of Marijuana and Opioids

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

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Key information

Conditions

Marijuana Use Behavior 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, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ages 18-50
  • Experience with marijuana and opioids
  • General good health
  • Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,

Exclusion criteria

  • Significant medical complications/conditions

Treatment and study plan

Marijuana

Drug

Double-blind administration of marijuana

Other names: Cannabis

Opioid

Drug

Double-blind administration of an opioid agonist

Primary outcomes

  1. Self-Administration of Drug Units Earned

    Time frame: Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session

    The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM).

Secondary outcomes

  1. Peak End-tidal Carbon Dioxide (EtCO2)

    Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).

    End-tidal Carbon Dioxide (EtCO2): For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). Higher scores indicate greater impairment.

  2. Trough Respiration Rate

    Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).

    Respiration rate (number of breaths per minute): For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). Lower scores indicate greater impairment.

Sponsors and collaborators

Lead sponsor

Shanna Babalonis, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2022
Registry last updated
Apr 15, 2026

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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