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Cannabinoid

Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products for Chronic Pain (ReLeaf-V Trial)

N/A
Waitlist Available
Led By Stephen Dahmer, MD
Research Sponsored by Vireo Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
Awards & highlights

ReLeaf-V Trial Summary

This trial will study if giving people with chronic pain vouchers for medical cannabis affects how much they use opioids. The results could help shape how medical cannabis is used and regulated.

Who is the study for?
This trial is for adults over 18 who speak English or Spanish, have a medical cannabis certification, and plan to use soft-gel capsule products from Vireo Health. They must be dealing with chronic pain or severe pain that could lead to opioid use disorder. Participants should have used opioid analgesics recently but not all criteria are shared publicly.Check my eligibility
What is being tested?
The study is testing if giving discounted vouchers for medical cannabis soft-gel capsules can reduce the reliance on opioids in adults suffering from chronic pain. The goal is to inform better clinical practices and policies regarding medical cannabis.See study design
What are the potential side effects?
While specific side effects of the medical cannabis soft-gel capsules aren't listed here, common ones may include dizziness, dry mouth, altered mental state, and potential dependency or withdrawal symptoms.

ReLeaf-V Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 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
Opioid analgesic use

ReLeaf-V Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Voucher for a Discounted Low THC:High CBD ProductExperimental Treatment1 Intervention
Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product
Group II: Voucher for a Discounted High THC:Low CBD ProductExperimental Treatment1 Intervention
Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product
Group III: Voucher for a Discounted Equal THC:CBD ProductExperimental Treatment1 Intervention
Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product
Group IV: Voucher for a Discounted Placebo ProductPlacebo Group1 Intervention
Voucher for a Discounted Placebo Soft-Gel Capsule Product

Find a Location

Who is running the clinical trial?

Vireo HealthLead Sponsor
3 Previous Clinical Trials
319 Total Patients Enrolled
1 Trials studying Chronic Pain
217 Patients Enrolled for Chronic Pain
Stephen Dahmer, MDPrincipal InvestigatorVireo Health of New York
Giovanna DiFrancescaStudy DirectorAlbert Einstein College of Medicine

Frequently Asked Questions

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

Does the current trial allow for further enrolment of participants?

"Affirmative, according to clinicaltrials.gov's records this trial is currently enrolling patients - it was initially posted on October 6th 2020 and last updated on June 29th 2022. 352 participants are being sought from a single medical facility."

Answered by AI

Is this research endeavor admitting participants aged 75 and over?

"This clinical trial permits patients aged 18 or higher to enroll, but the upper age limit is capped at 99."

Answered by AI

Am I apt to join this research experiment?

"This clinical trial is seeking 352 individuals aged between 18 to 99, who suffer from chronic pain. Additional criteria for inclusion are: fluency in English or Spanish, active certification for medical cannabis, intending to receive a soft-gel capsule product dispensed at Vireo Health, qualifying conditions related to either (a) severe and chronic pain; (b) joint or neuropathic agony; (c) current acute distress; and having been prescribed opioids analgesics within the last two months. For study reliability purposes, certain eligibility requirements remain undisclosed when recruiting participants."

Answered by AI

How many participants are eligible to join this clinical research trial?

"Confirmed, the clinicaltrials.gov page for this trial shows that it is currently recruiting participants. It initially went live on October 6th 2020 and was last modified on June 29th 2022. The goal of this study is to acquire 352 individuals from just one site."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
New York
How old are they?
18 - 65
What site did they apply to?
Vireo Health of New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain
2020. "Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04495725.
~60 spots leftby Apr 2025
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