Back to resultsOpioid and Cannabinoid Interactions
Primary Purpose
Marijuana Usage, Opioid Use
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vaporized Marijuana
Opioid Agonist
Sponsored by
About this trial
This is an interventional basic science trial for Marijuana Usage focused on measuring marijuana, opioid, opiate, cannabis
Eligibility Criteria
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
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Vaporized Marijuana
Opioid Agonist
Opioid Agonist/Marijuana Combination
Arm Description
Participants will receive non-therapeutic, experimental doses of active or placebo. vaporized marijuana. Active marijuana/placebo will be administered once per session and will be administered via a vaporizer.
Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intranasally (snorting).
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with non-therapeutic, experimental doses of active vaporized marijuana/placebo. Opioid/placebo and marijuana/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Outcomes
Primary Outcome Measures
Change in Subject-Rated Outcomes
Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.
Secondary Outcome Measures
Change in Oxygen Saturation
Oxygen saturation (measured as a percentage) will be monitored throughout each session.
Change in Respiration Rate
Respiration rate (number of breaths per minute)
Change in Blood pressure
Systolic and diastolic blood pressure (mm Hg)
Full Information
NCT ID
NCT03705559
First Posted
October 3, 2018
Last Updated
February 10, 2023
Sponsor
Shanna Babalonis, PhD
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03705559
Brief Title
Opioid and Cannabinoid Interactions
Official Title
Interactions of Marijuana and Opioids: Pharmacodynamic Effects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Usage, Opioid Use
Keywords
marijuana, opioid, opiate, cannabis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
This is a randomized, double-blind, double-dummy, placebo-controlled design
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaporized Marijuana
Arm Type
Experimental
Arm Description
Participants will receive non-therapeutic, experimental doses of active or placebo. vaporized marijuana. Active marijuana/placebo will be administered once per session and will be administered via a vaporizer.
Arm Title
Opioid Agonist
Arm Type
Experimental
Arm Description
Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intranasally (snorting).
Arm Title
Opioid Agonist/Marijuana Combination
Arm Type
Experimental
Arm Description
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with non-therapeutic, experimental doses of active vaporized marijuana/placebo. Opioid/placebo and marijuana/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Intervention Type
Drug
Intervention Name(s)
Vaporized Marijuana
Other Intervention Name(s)
Cannabis
Intervention Description
Active Marijuana or Placebo, administered through vaporizer
Intervention Type
Drug
Intervention Name(s)
Opioid Agonist
Intervention Description
Active Opioid Agonist or Placebo, administered intranasally
Primary Outcome Measure Information:
Title
Change in Subject-Rated Outcomes
Description
Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.
Time Frame
These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Secondary Outcome Measure Information:
Title
Change in Oxygen Saturation
Description
Oxygen saturation (measured as a percentage) will be monitored throughout each session.
Time Frame
Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Title
Change in Respiration Rate
Description
Respiration rate (number of breaths per minute)
Time Frame
Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Title
Change in Blood pressure
Description
Systolic and diastolic blood pressure (mm Hg)
Time Frame
Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanna Babalonis, Ph.D.
Phone
(859) 257-1881
Email
babalonis@uky.edu
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A. Nuzzo, M.A.
Phone
859-323-0002
Email
paul.nuzzo@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have no plans to share individual participant data with other researchers.
Learn more about this trial
Opioid and Cannabinoid Interactions
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