Clinical trial

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Name

7647

Description

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.

Trial arms

Trial start

2019-04-01

Estimated PCD

2022-12-06

Trial end

2022-12-06

Status

Completed

Phase

Early phase I

Treatment

Oxycodone

Oxycodone, 2.5 mg

Arms:

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

Cannabis (THC:CBD = ~ 1:0)

Cannabis with high THC concentration and negligible CBD concentrations

Arms:

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

Cannabis (THC:CBD = ~ 0:1)

Cannabis with high CBD concentration and negligible THC concentrations

Arms:

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

Cannabis (THC:CBD = ~ 1:1)

Cannabis with equivalent CBD and THC concentrations

Arms:

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

Placebo

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Arms:

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

Other names:

Placebo cannabis

Size

Primary endpoint

Subjective Effects

6 weeks

Cold Pressor Test

6 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

Updated at

2024-05-23

1 organization

2 products

1 drug

3 indications

Organization

New York State Psychiatric Institute

Product

Oxycodone

Indication

Pain