Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

December 2, 2024 updated by: Caroline A. Arout, Ph.D., New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 53 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)
Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Names:
  • Placebo cannabis
Experimental: Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Names:
  • Placebo cannabis
Drug: Oxycodone
Oxycodone, 2.5 mg
Experimental: Cannabis (THC:CBD = ~1:0)
Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Names:
  • Placebo cannabis
Drug: Cannabis (THC:CBD = ~ 1:0)
Cannabis with high THC concentration and negligible CBD concentrations
Experimental: Cannabis (THC:CBD = ~ 0:1)
Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Names:
  • Placebo cannabis
Drug: Cannabis (THC:CBD = ~ 0:1)
Cannabis with high CBD concentration and negligible THC concentrations
Experimental: Cannabis (THC:CBD = ~ 1:1)
Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)
Drug: Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Other Names:
  • Placebo cannabis
Drug: Cannabis (THC:CBD = ~ 1:1)
Cannabis with equivalent CBD and THC concentrations
Experimental: Cannabis (THC:CBD = ~1:0) + Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Drug: Oxycodone
Oxycodone, 2.5 mg
Drug: Cannabis (THC:CBD = ~ 1:0)
Cannabis with high THC concentration and negligible CBD concentrations
Experimental: Cannabis (THC:CBD = ~ 0:1) + Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Drug: Oxycodone
Oxycodone, 2.5 mg
Drug: Cannabis (THC:CBD = ~ 0:1)
Cannabis with high CBD concentration and negligible THC concentrations
Experimental: Cannabis (THC:CBD = ~ 1:1) + Oxycodone
Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)
Drug: Oxycodone
Oxycodone, 2.5 mg
Drug: Cannabis (THC:CBD = ~ 1:1)
Cannabis with equivalent CBD and THC concentrations

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Caroline A Cooper, PhD, New York Psychiatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

December 6, 2022

Study Completion (Actual)

December 6, 2022

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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