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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 : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Ziva D'vora Cooper, New York State Psychiatric Institute

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
Pain Abuse, Drug Drug: Oxycodone Drug: Cannabis (THC:CBD = ~ 1:0) Drug: Cannabis (THC:CBD = ~ 0:1) Drug: Cannabis (THC:CBD = ~ 1:1) Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Subjective Effects [ Time Frame: 6 weeks ]
    Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 53 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03679949


Contacts
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Contact: Ziva D Cooper, PhD 646-774-6159 zc2160@cumc.columbia.edu
Contact: Caroline A Arout, PhD 646-774-6167 caroline.arout@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Caroline A Arout, PhD    646-774-6167    caroline.arout@nyspi.columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Ziva D Cooper, PhD Columbia University Irving Medical Center

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Responsible Party: Ziva D'vora Cooper, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03679949     History of Changes
Other Study ID Numbers: 7647
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Ziva D'vora Cooper, New York State Psychiatric Institute:
experimental pain
Cannabis
Cannabidiol
THC

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents