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NCT03679949 Clinical Trial

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Pain Clinical Trial

Official title:
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03679949
Other study ID # 7647
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2019
Est. completion date July 1, 2024

Study information
Verified date July 2023
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 26
Est. completion date July 1, 2024
Est. primary completion date January 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 53 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone
Oxycodone, 2.5 mg
• Cannabis (THC:CBD = ~ 1:0)
Cannabis with high THC concentration and negligible CBD concentrations
• Cannabis (THC:CBD = ~ 0:1)
Cannabis with high CBD concentration and negligible THC concentrations
• Cannabis (THC:CBD = ~ 1:1)
Cannabis with equivalent CBD and THC concentrations
• Placebo
Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Locations
Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)
Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

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