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Opioid and Cannabinoid Interactions

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ClinicalTrials.gov Identifier: NCT03705559
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shanna Babalonis, PhD, University of Kentucky

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date April 4, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
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 hrs per session). ]
Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.
Change History Complete list of historical versions of study NCT03705559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • 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.
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • 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 hrs per session). ]
    Oxygen saturation (measured as a percentage) will be monitored throughout each session.
  • 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 hrs per session). ]
    Respiration rate (number of breaths per minute)
  • 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 hrs per session). ]
    Systolic and diastolic blood pressure (mm Hg)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid and Cannabinoid Interactions
Official Title  ICMJE Interactions of Marijuana and Opioids: Pharmacodynamic Effects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Marijuana Usage
  • Opioid Use
Intervention  ICMJE
  • Drug: Vaporized Marijuana
    Active Marijuana or Placebo, administered through vaporizer
    Other Name: Cannabis
  • Drug: Opioid Agonist
    Active Opioid Agonist or Placebo, administered intranasally
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Vaporized Marijuana
  • 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).
    Intervention: Drug: Opioid Agonist
  • 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.
    Interventions:
    • Drug: Vaporized Marijuana
    • Drug: Opioid Agonist
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2018)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shanna Babalonis, Ph.D. (859) 257-1881 babalonis@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03705559
Other Study ID Numbers  ICMJE 45017
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
Plan Description: We have no plans to share individual participant data with other researchers.
Responsible Party Shanna Babalonis, PhD, University of Kentucky
Study Sponsor  ICMJE Shanna Babalonis, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kentucky
Verification Date April 2019

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