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Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03679949
Collaborator
(none)
26
Enrollment
1
Location
8
Arms
51
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxycodone
  • Drug: Cannabis (THC:CBD = ~ 1:0)
  • Drug: Cannabis (THC:CBD = ~ 0:1)
  • Drug: Cannabis (THC:CBD = ~ 1:1)
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
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.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
Official Title:
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)

Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Names:
  • Placebo cannabis

    		•
    Experimental: Oxycodone

    Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)

    Drug: Oxycodone
    Oxycodone, 2.5 mg

    Drug: Placebo
    Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
    Other Names:
  • Placebo cannabis

    		•
    Experimental: Cannabis (THC:CBD = ~1:0)

    Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

    Drug: Cannabis (THC:CBD = ~ 1:0)
    Cannabis with high THC concentration and negligible CBD concentrations

    Drug: Placebo
    Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
    Other Names:
  • Placebo cannabis

    		•
    Experimental: Cannabis (THC:CBD = ~ 0:1)

    Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

    Drug: Cannabis (THC:CBD = ~ 0:1)
    Cannabis with high CBD concentration and negligible THC concentrations

    Drug: Placebo
    Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
    Other Names:
  • Placebo cannabis

    		•
    Experimental: Cannabis (THC:CBD = ~ 1:1)

    Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)

    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 Names:
  • Placebo cannabis

    		•
    Experimental: Cannabis (THC:CBD = ~1:0) + Oxycodone

    Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

    Drug: Oxycodone
    Oxycodone, 2.5 mg

    Drug: Cannabis (THC:CBD = ~ 1:0)
    Cannabis with high THC concentration and negligible CBD concentrations
    Experimental: Cannabis (THC:CBD = ~ 0:1) + Oxycodone

    Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

    Drug: Oxycodone
    Oxycodone, 2.5 mg

    Drug: Cannabis (THC:CBD = ~ 0:1)
    Cannabis with high CBD concentration and negligible THC concentrations
    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)

    Drug: Oxycodone
    Oxycodone, 2.5 mg

    Drug: Cannabis (THC:CBD = ~ 1:1)
    Cannabis with equivalent CBD and THC concentrations

    Outcome Measures

    Primary Outcome Measures

    1. Subjective Effects [6 weeks]

      Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).

    2. Cold Pressor Test [6 weeks]

      Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 53 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York State Psychiatric Institute New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute

    Investigators

    • Principal Investigator: Caroline A Cooper, PhD, New York Psychiatric Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Caroline A. Arout, Ph.D., Research Scientist, New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT03679949
    Other Study ID Numbers:
    • 7647
    First Posted:
    Sep 21, 2018
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Caroline A. Arout, Ph.D., Research Scientist, New York State Psychiatric Institute
    experimental pain
    Cannabis
    Cannabidiol
    THC
    Additional relevant MeSH terms:
    Marijuana Abuse
    Substance-Related Disorders
    Oxycodone

    Study Results

    No Results Posted as of Sep 30, 2021