Back to resultsReinforcing Effects of Marijuana and Opioids
Primary Purpose
Marijuana Use, Opioid Use
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Marijuana
Opioid
Sponsored by
About this trial
This is an interventional basic science trial for Marijuana Use focused on measuring marijuana, opioid, healthy participants, laboratory study
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Double-blind marijuana/placebo administration
Double-blind opioid/placebo administration
Arm Description
Participants will receive double-blind administration of vaporized marijuana/placebo
Participants will receive double-blind administration of intranasal opioid agonist/placebo
Outcomes
Primary Outcome Measures
Self-Administration
The number of units of drug earned in each session
Secondary Outcome Measures
Subjective measures
Ratings of drug effects (e.g., feeling high, impaired, good drug effects)
Heart rate
Beats per minute
Blood pressure
Systolic and diastolic blood pressure (mm/hg)
Full Information
NCT ID
NCT05485012
First Posted
July 18, 2022
Last Updated
July 6, 2023
Sponsor
Shanna Babalonis, PhD
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05485012
Brief Title
Reinforcing Effects of Marijuana and Opioids
Official Title
Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shanna Babalonis, PhD
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Use, Opioid Use
Keywords
marijuana, opioid, healthy participants, laboratory study
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double-blind marijuana/placebo administration
Arm Type
Experimental
Arm Description
Participants will receive double-blind administration of vaporized marijuana/placebo
Arm Title
Double-blind opioid/placebo administration
Arm Type
Experimental
Arm Description
Participants will receive double-blind administration of intranasal opioid agonist/placebo
Intervention Type
Drug
Intervention Name(s)
Marijuana
Other Intervention Name(s)
Cannabis
Intervention Description
Double-blind administration of marijuana
Intervention Type
Drug
Intervention Name(s)
Opioid
Intervention Description
Double-blind administration of an opioid agonist
Primary Outcome Measure Information:
Title
Self-Administration
Description
The number of units of drug earned in each session
Time Frame
Collected once during each self-administration session
Secondary Outcome Measure Information:
Title
Subjective measures
Description
Ratings of drug effects (e.g., feeling high, impaired, good drug effects)
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)
Title
Heart rate
Description
Beats per minute
Time Frame
Baseline, post-dose during each session (change from baseline is assessed)
Title
Blood pressure
Description
Systolic and diastolic blood pressure (mm/hg)
Time Frame
Baseline, post-dose during each session (change from baseline is assessed)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Nuzzo
Phone
(859) 323-0002
Email
pnuzz2@email.uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanna Babalonis, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Reinforcing Effects of Marijuana and Opioids
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