Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Phase 1

Completed

• Conditions: Pain; Abuse, Drug
• Interventions: Drug: Placebo; Drug: Oxycodone

• Registration Number: NCT03679949
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Study Start: 2019-04-01
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)
Oxycodone	Placebo	Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
Cannabis (THC:CBD = ~1:0)	Placebo	Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Cannabis (THC:CBD = ~ 0:1)	Placebo	Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Cannabis (THC:CBD = ~ 1:1)	Placebo	Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)
Oxycodone	Oxycodone	Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
Cannabis (THC:CBD = ~1:0) + Oxycodone	Oxycodone	Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Cannabis (THC:CBD = ~ 0:1) + Oxycodone	Oxycodone	Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Cannabis (THC:CBD = ~ 1:1) + Oxycodone	Oxycodone	Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)

Primary Outcome Measures

Name	Time	Method
Subjective Effects	6 weeks	Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).
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).

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States