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Clinical Trials/NCT03679949
NCT03679949
Completed
Phase 1

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

New York State Psychiatric Institute1 site in 1 country26 target enrollmentApril 1, 2019

Overview

Phase
Phase 1
Intervention
Placebo
Conditions
Pain
Sponsor
New York State Psychiatric Institute
Enrollment
26
Locations
1
Primary Endpoint
Subjective Effects
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
December 6, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caroline A. Arout, Ph.D.

Research Scientist

New York State Psychiatric Institute

Eligibility 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

Arms & Interventions

Placebo

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

Intervention: Placebo

Oxycodone

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

Intervention: Oxycodone

Oxycodone

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

Intervention: Placebo

Cannabis (THC:CBD = ~1:0)

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

Intervention: Placebo

Cannabis (THC:CBD = ~ 0:1)

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

Intervention: Placebo

Cannabis (THC:CBD = ~ 1:1)

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

Intervention: Placebo

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

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

Intervention: Oxycodone

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

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

Intervention: Oxycodone

Cannabis (THC:CBD = ~ 1:1) + Oxycodone

Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)

Intervention: Oxycodone

Outcomes

Primary Outcomes

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).

Study Sites (1)

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