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Opioid and Cannabinoid Interactions

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ClinicalTrials.gov Identifier: NCT03705559
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shanna Babalonis, PhD, University of Kentucky

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: This is a randomized, double-blind, double-dummy, placebo-controlled design
Primary Purpose: Basic Science
Official Title: Interactions of Marijuana and Opioids: Pharmacodynamic Effects
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaporized Marijuana
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.
Drug: Vaporized Marijuana
Active Marijuana or Placebo, administered through vaporizer
Other Name: Cannabis

Experimental: Opioid Agonist
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).
Drug: Opioid Agonist
Active Opioid Agonist or Placebo, administered intranasally

Experimental: Opioid Agonist/Marijuana Combination
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.
Drug: Vaporized Marijuana
Active Marijuana or Placebo, administered through vaporizer
Other Name: Cannabis

Drug: Opioid Agonist
Active Opioid Agonist or Placebo, administered intranasally




Primary Outcome Measures :
  1. Change in Subject-Rated Outcomes [ 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). ]
    Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.


Secondary Outcome Measures :
  1. Change in Oxygen Saturation [ 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). ]
    Oxygen saturation (measured as a percentage) will be monitored throughout each session.

  2. Change in Respiration Rate [ 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). ]
    Respiration rate (number of breaths per minute)

  3. Change in Blood pressure [ 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). ]
    Systolic and diastolic blood pressure (mm Hg)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03705559


Contacts
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Contact: Shanna Babalonis, Ph.D. (859) 257-1881 babalonis@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40508
Contact: Paul A. Nuzzo, M.A.    859-323-0002    paul.nuzzo@uky.edu   
Sponsors and Collaborators
Shanna Babalonis, PhD

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Responsible Party: Shanna Babalonis, PhD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03705559     History of Changes
Other Study ID Numbers: 45017
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plans to share individual participant data with other researchers.

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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
opiate
cannabis
Additional relevant MeSH terms:
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Marijuana Abuse
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