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Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

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ClinicalTrials.gov Identifier: NCT03679949
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Caroline Arout, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE September 19, 2018
First Posted Date  ICMJE September 21, 2018
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • Subjective Effects [ Time Frame: 6 weeks ]
    Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).
  • Cold Pressor Test [ Time Frame: 6 weeks ]
    Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Official Title  ICMJE Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Brief Summary The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pain
  • Abuse, Drug
Intervention  ICMJE
  • Drug: Oxycodone
    Oxycodone, 2.5 mg
  • Drug: Cannabis (THC:CBD = ~ 1:0)
    Cannabis with high THC concentration and negligible CBD concentrations
  • Drug: Cannabis (THC:CBD = ~ 0:1)
    Cannabis with high CBD concentration and negligible THC concentrations
  • Drug: Cannabis (THC:CBD = ~ 1:1)
    Cannabis with equivalent CBD and THC concentrations
  • Drug: Placebo
    Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
    Other Name: Placebo cannabis
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)
    Intervention: Drug: Placebo
  • Experimental: Oxycodone
    Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
    Interventions:
    • Drug: Oxycodone
    • Drug: Placebo
  • Experimental: Cannabis (THC:CBD = ~1:0)
    Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
    Interventions:
    • Drug: Cannabis (THC:CBD = ~ 1:0)
    • Drug: Placebo
  • Experimental: Cannabis (THC:CBD = ~ 0:1)
    Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
    Interventions:
    • Drug: Cannabis (THC:CBD = ~ 0:1)
    • Drug: Placebo
  • Experimental: Cannabis (THC:CBD = ~ 1:1)
    Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)
    Interventions:
    • Drug: Cannabis (THC:CBD = ~ 1:1)
    • Drug: Placebo
  • Experimental: Cannabis (THC:CBD = ~1:0) + Oxycodone
    Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
    Interventions:
    • Drug: Oxycodone
    • Drug: Cannabis (THC:CBD = ~ 1:0)
  • Experimental: Cannabis (THC:CBD = ~ 0:1) + Oxycodone
    Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
    Interventions:
    • Drug: Oxycodone
    • Drug: Cannabis (THC:CBD = ~ 0:1)
  • Experimental: Cannabis (THC:CBD = ~ 1:1) + Oxycodone
    Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)
    Interventions:
    • Drug: Oxycodone
    • Drug: Cannabis (THC:CBD = ~ 1:1)
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: September 20, 2018)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non-pregnant female aged 21-53 years
  • Previous cannabis use
  • Previous opioid use
  • Urine test positive for recent cannabis use
  • Being able to perform all study procedures
  • Currently practicing an effective form of birth control (women only)

Exclusion Criteria:

  • Meeting criteria for some Use Disorders
  • Report regular illicit drug use
  • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 53 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Caroline A Arout, PhD 646-774-6167 caroline.arout@nyspi.columbia.edu
Contact: Ziva D Cooper, PhD 310-206-9942 zcooper@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03679949
Other Study ID Numbers  ICMJE 7647
Has Data Monitoring Committee Yes
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: Undecided
Responsible Party Caroline Arout, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caroline A Cooper, PhD New York Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date April 2020

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