Opioid UseReLeaf-VNCT04495725
Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain
A study testing Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products in people with Opioid Use and Marijuana, run by Vireo Health at 1 site in United States.
Trial summary
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use, Marijuana, Chronic Pain
- What is being tested?
- Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- English or Spanish fluency
- active certification for medical cannabis
- intends to have a soft-gel capsule product dispensed at Vireo Health
- medical cannabis qualifying conditions or complications of (a) chronic pain, or (b) pain that degrades health and functional capability as an alternative to opioid use or substance use disorder or (c) severe or chronic pain
- joint or neuropathic pain
Show all 9Show fewer
- current severe pain
- dispensed opioids analgesics within the last 60 days
- To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants.
Who cannot join
- inability to provide informed consent
- inability to complete study visits over 14 weeks
- terminal illness
- current or prior psychotic disorder
- current or prior buprenorphine or methadone treatment for opioid use disorder
- NYS medical marijuana prescriber does not approve changes to product and dosing recommendations listed on the participant's certification form
Show all 9Show fewer
- Allergy to tapioca or coconut
- currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
- a condition that is considered by a pharmacist or medical provider to be a clinical contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-drug interaction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies.
Read the detailed description
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid analgesic use, and (c) active certification for medical cannabis. We will randomize participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records. The primary independent variable will be randomization arm, and the primary outcome will be cumulative opioid analgesic dose.
- Conditions
- Opioid Use, Marijuana, Chronic Pain
- Being tested
- Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products
- Keywords
- opioid, marijuana, cannabis, pain
- Medical subject headings
- Marijuana Abuse, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discounted Vouchers for Medical Cannabis Soft-Gel Capsule ProductsOther
We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.
| Study group | Role | What they receive |
|---|---|---|
| Voucher for a Discounted Placebo Product | Placebo comparator | Voucher for a Discounted Placebo Soft-Gel Capsule Product Receives: Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products |
| Voucher for a Discounted High THC:Low CBD Product | Experimental | Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product Receives: Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products |
| Voucher for a Discounted Equal THC:CBD Product | Experimental | Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product Receives: Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products |
| Voucher for a Discounted Low THC:High CBD Product | Experimental | Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product Receives: Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid analgesic use
The primary outcome will be cumulative opioid analgesic dose.
Measured: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start6 Oct 2020
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vireo Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Dahmer, MD, Principal investigator, Vireo Health of New YorkGiovanna DiFrancesca, Study director, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495725
- Sponsor's protocol ID
- ReLeaf-V
- Acronym
- ReLeaf-V
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)
- ClinicalTrials.gov ID
- NCT04495725
- Acronym / sponsor ID
- ReLeaf-V / ReLeaf-V
- Conditions
- Opioid Use, Marijuana, Chronic Pain
- Keywords
- opioid, marijuana, cannabis, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Vireo HealthUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies.
Detailed description
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid analgesic use, and (c) active certification for medical cannabis. We will randomize participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records. The primary independent variable will be randomization arm, and the primary outcome will be cumulative opioid analgesic dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Voucher for a Discounted Placebo Product | Placebo comparator | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule ProductsVoucher for a Discounted Placebo Soft-Gel Capsule Product |
| Voucher for a Discounted High THC:Low CBD Product | Experimental | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule ProductsVoucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product |
| Voucher for a Discounted Equal THC:CBD Product | Experimental | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule ProductsVoucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product |
| Voucher for a Discounted Low THC:High CBD Product | Experimental | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule ProductsVoucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >18 years old
- English or Spanish fluency
- active certification for medical cannabis
- intends to have a soft-gel capsule product dispensed at Vireo Health
- medical cannabis qualifying conditions or complications of (a) chronic pain, or (b) pain that degrades health and functional capability as an alternative to opioid use or substance use disorder or (c) severe or chronic pain
Key exclusion criteria (9 listed)
- inability to provide informed consent
- inability to complete study visits over 14 weeks
- terminal illness
- current or prior psychotic disorder
- current or prior buprenorphine or methadone treatment for opioid use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discounted Vouchers for Medical Cannabis Soft-Gel Capsule ProductsWe will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time. | Other | Voucher for a Discounted Equal THC:CBD Product, Voucher for a Discounted High THC:Low CBD Product, Voucher for a Discounted Low THC:High CBD Product, Voucher for a Discounted Placebo Product |
Primary outcome
Opioid analgesic use
Time frame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
The primary outcome will be cumulative opioid analgesic dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Dahmer, MD principal investigator
Vireo Health of New York
Giovanna DiFrancesca study director
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products in people with Opioid Use and Marijuana, run by Vireo Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid analgesic use (time frame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.