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Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Primary Purpose

Pain, Abuse, Drug

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Cannabis (THC:CBD = ~ 1:0)
Cannabis (THC:CBD = ~ 0:1)
Cannabis (THC:CBD = ~ 1:1)
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring experimental pain, Cannabis, Cannabidiol, THC

Eligibility Criteria

21 Years - 53 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Oxycodone

Cannabis (THC:CBD = ~1:0)

Cannabis (THC:CBD = ~ 0:1)

Cannabis (THC:CBD = ~ 1:1)

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

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

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

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Subjective Effects
Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).
Cold Pressor Test
Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).

Secondary Outcome Measures

Full Information

First Posted
September 19, 2018
Last Updated
July 30, 2023
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03679949
Brief Title
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Official Title
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Abuse, Drug
Keywords
experimental pain, Cannabis, Cannabidiol, THC

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)
Arm Title
Oxycodone
Arm Type
Experimental
Arm Description
Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
Arm Title
Cannabis (THC:CBD = ~1:0)
Arm Type
Experimental
Arm Description
Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Arm Title
Cannabis (THC:CBD = ~ 0:1)
Arm Type
Experimental
Arm Description
Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Arm Title
Cannabis (THC:CBD = ~ 1:1)
Arm Type
Experimental
Arm Description
Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)
Arm Title
Cannabis (THC:CBD = ~1:0) + Oxycodone
Arm Type
Experimental
Arm Description
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Arm Title
Cannabis (THC:CBD = ~ 0:1) + Oxycodone
Arm Type
Experimental
Arm Description
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Arm Title
Cannabis (THC:CBD = ~ 1:1) + Oxycodone
Arm Type
Experimental
Arm Description
Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Oxycodone, 2.5 mg
Intervention Type
Drug
Intervention Name(s)
Cannabis (THC:CBD = ~ 1:0)
Intervention Description
Cannabis with high THC concentration and negligible CBD concentrations
Intervention Type
Drug
Intervention Name(s)
Cannabis (THC:CBD = ~ 0:1)
Intervention Description
Cannabis with high CBD concentration and negligible THC concentrations
Intervention Type
Drug
Intervention Name(s)
Cannabis (THC:CBD = ~ 1:1)
Intervention Description
Cannabis with equivalent CBD and THC concentrations
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo cannabis
Intervention Description
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
Primary Outcome Measure Information:
Title
Subjective Effects
Description
Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).
Time Frame
6 weeks
Title
Cold Pressor Test
Description
Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline A Cooper, PhD
Organizational Affiliation
New York Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

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