Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

NCT ID: NCT03679949

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-12-06

Brief Summary

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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

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Conditions

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Pain Abuse, Drug

Keywords

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experimental pain Cannabis Cannabidiol THC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Oxycodone

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

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

Oxycodone, 2.5 mg

Placebo

Intervention Type DRUG

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Cannabis (THC:CBD = ~1:0)

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

Group Type EXPERIMENTAL

Cannabis (THC:CBD = ~ 1:0)

Intervention Type DRUG

Cannabis with high THC concentration and negligible CBD concentrations

Placebo

Intervention Type DRUG

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Cannabis (THC:CBD = ~ 0:1)

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

Group Type EXPERIMENTAL

Cannabis (THC:CBD = ~ 0:1)

Intervention Type DRUG

Cannabis with high CBD concentration and negligible THC concentrations

Placebo

Intervention Type DRUG

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Cannabis (THC:CBD = ~ 1:1)

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

Group Type EXPERIMENTAL

Cannabis (THC:CBD = ~ 1:1)

Intervention Type DRUG

Cannabis with equivalent CBD and THC concentrations

Placebo

Intervention Type DRUG

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

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

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

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

Oxycodone, 2.5 mg

Cannabis (THC:CBD = ~ 1:0)

Intervention Type DRUG

Cannabis with high THC concentration and negligible CBD concentrations

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

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

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

Oxycodone, 2.5 mg

Cannabis (THC:CBD = ~ 0:1)

Intervention Type DRUG

Cannabis with high CBD concentration and negligible THC concentrations

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

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

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

Oxycodone, 2.5 mg

Cannabis (THC:CBD = ~ 1:1)

Intervention Type DRUG

Cannabis with equivalent CBD and THC concentrations

Interventions

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Oxycodone

Oxycodone, 2.5 mg

Intervention Type DRUG

Cannabis (THC:CBD = ~ 1:0)

Cannabis with high THC concentration and negligible CBD concentrations

Intervention Type DRUG

Cannabis (THC:CBD = ~ 0:1)

Cannabis with high CBD concentration and negligible THC concentrations

Intervention Type DRUG

Cannabis (THC:CBD = ~ 1:1)

Cannabis with equivalent CBD and THC concentrations

Intervention Type DRUG

Placebo

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Intervention Type DRUG

Other Intervention Names

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Placebo cannabis

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

53 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Caroline A. Arout, Ph.D.

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline A Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

New York Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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7647

Identifier Type: -

Identifier Source: org_study_id