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Opioid Analgesic

Cannabis for Pain Management

Phase 1
Waitlist Available
Led By Caroline A Cooper, PhD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Being able to perform all study procedures
Male or non-pregnant female aged 21-53 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will test if cannabis has an impact on the pain-relieving and abuse-potential effects of a sub-threshold dose of a common painkiller.

Who is the study for?
This trial is for adults aged 21-53 who have used cannabis and opioids before, can do all study tasks, and are not pregnant (women must use birth control). It's not for those with significant illness or certain substance use disorders.Check my eligibility
What is being tested?
The study tests how different forms of cannabis affect pain relief and the potential for prescription drug abuse when taken with a low dose of oxycodone. Participants will try THC-only, CBD-only, equal THC:CBD mixtures, or placebo.See study design
What are the potential side effects?
Cannabis may cause dizziness, dry mouth, altered mental state or mood changes. Oxycodone can lead to nausea, constipation, addiction risk and respiratory depression if misused.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can participate in all required study activities.
Select...
I am between 21 and 53 years old and not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cold Pressor Test
Subjective Effects

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: OxycodoneExperimental Treatment2 Interventions
Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)
Group II: Cannabis (THC:CBD = ~1:0) + OxycodoneExperimental Treatment2 Interventions
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Group III: Cannabis (THC:CBD = ~1:0)Experimental Treatment2 Interventions
Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)
Group IV: Cannabis (THC:CBD = ~ 1:1) + OxycodoneExperimental Treatment2 Interventions
Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)
Group V: Cannabis (THC:CBD = ~ 1:1)Experimental Treatment2 Interventions
Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)
Group VI: Cannabis (THC:CBD = ~ 0:1) + OxycodoneExperimental Treatment2 Interventions
Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Group VII: Cannabis (THC:CBD = ~ 0:1)Experimental Treatment2 Interventions
Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)
Group VIII: PlaceboPlacebo Group1 Intervention
Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Oxycodone
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
474 Previous Clinical Trials
153,231 Total Patients Enrolled
5 Trials studying Substance Abuse
1,115 Patients Enrolled for Substance Abuse
Caroline A Cooper, PhDPrincipal InvestigatorNew York Psychiatric Institute

Media Library

Oxycodone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03679949 — Phase 1
Substance Abuse Research Study Groups: Cannabis (THC:CBD = ~1:0), Cannabis (THC:CBD = ~ 0:1) + Oxycodone, Cannabis (THC:CBD = ~ 1:1) + Oxycodone, Cannabis (THC:CBD = ~ 0:1), Cannabis (THC:CBD = ~ 1:1), Cannabis (THC:CBD = ~1:0) + Oxycodone, Placebo, Oxycodone
Substance Abuse Clinical Trial 2023: Oxycodone Highlights & Side Effects. Trial Name: NCT03679949 — Phase 1
Oxycodone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03679949 — Phase 1
Substance Abuse Patient Testimony for trial: Trial Name: NCT03679949 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study currently require new participants?

"Affirmative. The information posted on clinicaltrials.gov indicates that this medical research is actively trying to recruit participants, having first been published in April of 2019 with revisions made in September 2022. A total of 26 individuals are needed across one site for the trial."

Answered by AI

Who qualifies to partake in this research initiative?

"This research project is attempting to gather 26 test subjects afflicted with pain, aged between 21 and 53. Crucially, applicants must have a prior history of opioid use, be either male or female if not pregnant, and have used cannabis in the past."

Answered by AI

What is the number of participants in this clinical venture?

"Yes, according to clinicaltrials.gov records, this trial remains open for recruitment and has been since April 1st 2019 - the date of its initial posting. 26 participants are needed from a single location before it is closed on September 26th 2022."

Answered by AI

What is the safety profile of a 1:1 THC to CBD ratio Cannabis product?

"Due to the limited data for both safety and efficacy, Cannabis (THC:CBD = ~ 1:1) was assigned a score of 1 on our team's scale."

Answered by AI

Is there an age cut-off for recruitment into this research program?

"This clinical trial is open to individuals aged between 21 and 53 years old."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I use marijuana. Most drugs don’t work for my pain. So I joined the study hoping to help make a change so people like me will have access to pain relieving medication.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. New York State Psychiatric Institute: < 24 hours
~4 spots leftby Mar 2025