๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-06

Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial (NCT07148206)

๐ŸŸก Not Yet Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Montefiore Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating buprenorphine. The investigator team proposes to test the effectiveness of combined dronabinol (synthetic delta-9-tetrahydrocannabinol \[THC\]) and Epidiolex (cannabidiol \[CBD\]) - two FDA-approved cannabinoids - to improve retention in buprenorphine treatment and reduce opioid use among POUD who are early in treatment. POUD who are early in treatment are at a critical juncture-a moment of opportunity and motivation, but also of high risk of return to opioid use and loss to follow up.

Who can join: Review the eligibility criteria below.

Location: Montefiore Health System (Montefiore) Buprenorphine Treatment Network โ€” The Bronx, New York

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Montefiore Health System (Montefiore) Buprenorphine Treatment Network โ€” The Bronx, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (718) 920-3786

Email: dslawek@montefiore.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—