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Reinforcing Effects of Marijuana and Opioids

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ClinicalTrials.gov Identifier: NCT05485012
Recruitment Status : Recruiting
First Posted : August 2, 2022
Last Update Posted : October 30, 2023
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Shanna Babalonis, PhD, University of Kentucky

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Marijuana Use Opioid Use Drug: Marijuana Drug: Opioid Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
Actual Study Start Date : August 3, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: Double-blind marijuana/placebo administration
Participants will receive double-blind administration of vaporized marijuana/placebo
 Drug: Marijuana
Double-blind administration of marijuana
Other Name: Cannabis

Drug: Opioid
Double-blind administration of an opioid agonist
Experimental: Double-blind opioid/placebo administration
Participants will receive double-blind administration of intranasal opioid agonist/placebo
 Drug: Marijuana
Double-blind administration of marijuana
Other Name: Cannabis

Drug: Opioid
Double-blind administration of an opioid agonist


Outcome Measures
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Primary Outcome Measures :
  1. Self-Administration [ Time Frame: Collected once during each self-administration session ]
    The number of units of drug earned in each session


Secondary Outcome Measures :
  1. Subjective measures [ Time Frame: Baseline, post-dose during each session (change from baseline is assessed); visual analog scales will be the primary measure (0-100, 0=not at all, 100=extremely) ]
    Ratings of drug effects (e.g., feeling high, impaired, good drug effects)

  2. Heart rate [ Time Frame: Baseline, post-dose during each session (change from baseline is assessed) ]
    Beats per minute

  3. Blood pressure [ Time Frame: Baseline, post-dose during each session (change from baseline is assessed) ]
    Systolic and diastolic blood pressure (mm/hg)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05485012


Contacts
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Contact: Paul Nuzzo (859) 323-0002 pnuzz2@email.uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Paul Nuzzo    859-323-0002    pnuzz2@email.uky.edu   
Sponsors and Collaborators
Shanna Babalonis, PhD
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Shanna Babalonis, PhD University of Kentucky
More Information
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Responsible Party: Shanna Babalonis, PhD, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT05485012    
Other Study ID Numbers: 45017-20221
R01DA045700 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2022    Key Record Dates
Last Update Posted: October 30, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanna Babalonis, PhD, University of Kentucky:
marijuana
opioid
healthy participants
laboratory study
Additional relevant MeSH terms:
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Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents