Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

NCT03679949 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 7647
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Abuse, Drug

Keywords

experimental pain; Cannabis; Cannabidiol; THC

Outcome Measures

Primary Outcomes (2)

• Subjective Effects

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

  6 weeks

• Cold Pressor Test

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

  6 weeks

Study Arms (8)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Oxycodone

EXPERIMENTAL

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

Drug: Oxycodone; Drug: Placebo

Cannabis (THC:CBD = ~1:0)

EXPERIMENTAL

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

Drug: Cannabis (THC:CBD = ~ 1:0); Drug: Placebo

Cannabis (THC:CBD = ~ 0:1)

EXPERIMENTAL

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

Drug: Cannabis (THC:CBD = ~ 0:1); Drug: Placebo

Cannabis (THC:CBD = ~ 1:1)

EXPERIMENTAL

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

Drug: Cannabis (THC:CBD = ~ 1:1); Drug: Placebo

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

EXPERIMENTAL

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

Drug: Oxycodone; Drug: Cannabis (THC:CBD = ~ 1:0)

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

EXPERIMENTAL

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

Drug: Oxycodone; Drug: Cannabis (THC:CBD = ~ 0:1)

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

EXPERIMENTAL

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

Drug: Oxycodone; Drug: Cannabis (THC:CBD = ~ 1:1)

Interventions

Oxycodone DRUG

Oxycodone, 2.5 mg

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

Cannabis (THC:CBD = ~ 1:0) DRUG

Cannabis with high THC concentration and negligible CBD concentrations

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

Cannabis (THC:CBD = ~ 0:1) DRUG

Cannabis with high CBD concentration and negligible THC concentrations

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

Cannabis (THC:CBD = ~ 1:1) DRUG

Cannabis with equivalent CBD and THC concentrations

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

Placebo DRUG

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Also known as: Placebo cannabis

Cannabis (THC:CBD = ~ 0:1); Cannabis (THC:CBD = ~ 1:1); Cannabis (THC:CBD = ~1:0); Oxycodone; Placebo

Eligibility Criteria

• Age: 21 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pain; Substance-Related Disorders; Marijuana Abuse

Interventions

Oxycodone; nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Caroline A Cooper, PhD

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: April 1, 2019
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (1)