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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

Tracking Information
First Submitted Date  ICMJE July 18, 2022
First Posted Date  ICMJE August 2, 2022
Last Update Posted Date October 30, 2023
Actual Study Start Date  ICMJE August 3, 2023
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2022)		 Self-Administration [ Time Frame: Collected once during each self-administration session ]
The number of units of drug earned in each session
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2022)
  • 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)
  • Heart rate [ Time Frame: Baseline, post-dose during each session (change from baseline is assessed) ]
    Beats per minute
  • Blood pressure [ Time Frame: Baseline, post-dose during each session (change from baseline is assessed) ]
    Systolic and diastolic blood pressure (mm/hg)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reinforcing Effects of Marijuana and Opioids
Official Title  ICMJE Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Marijuana Use
  • Opioid Use
Intervention  ICMJE
  • Drug: Marijuana
    Double-blind administration of marijuana
    Other Name: Cannabis
  • Drug: Opioid
    Double-blind administration of an opioid agonist
Study Arms  ICMJE
  • Experimental: Double-blind marijuana/placebo administration
    Participants will receive double-blind administration of vaporized marijuana/placebo
    Interventions:
    • Drug: Marijuana
    • Drug: Opioid
  • Experimental: Double-blind opioid/placebo administration
    Participants will receive double-blind administration of intranasal opioid agonist/placebo
    Interventions:
    • Drug: Marijuana
    • Drug: Opioid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2022)		 12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Paul Nuzzo (859) 323-0002 pnuzz2@email.uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05485012
Other Study ID Numbers  ICMJE 45017-20221
R01DA045700 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shanna Babalonis, PhD, University of Kentucky
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shanna Babalonis, PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Shanna Babalonis, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP