Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder
Completed · Phase 2 · NCT06384157
Conditions: Opioid Use Disorder
At a glance
- Research payments reported, 2025
- $10.4M
- U.S. investigators named
- 36
- Sites paid
- 61
- Planned or actual enrollment
- 300
About the trial
- Sponsor
- Indivior Inc.
- Tested
- INDV-2000 (drug), Placebo (other)
- Dates
- Started 2024-06-10; completion 2025-11-03
- Results posted
- Not yet
The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non opioid treatment.
From ClinicalTrials.gov, last updated 2025-12-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Indivior Inc. reported $10.4M in research payments for this study in 2025 (845 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Brent E. Boyett, DMD, DO Family Medicine · Hamilton, AL
- Amirarsalan Eissa, M.D. Addiction Medicine · Phoenix, AZ
- Joseph L. Lillo, DO, FNLA, FAPCR Family Medicine · Scottsdale, AZ
- Eric M. Chavez, MD Psychiatry · San Diego, CA
- Valentin Isacescu, M.D. Psychiatry · Oceanside, CA
- Yogesh K. Paliwal, MD Cardiology · Pomona, CA
- James L. Andersen, M.D. Addiction Medicine · Eagle Lake, FL
- George P. Azar JR., M.D., PA Critical Care Medicine · Ft Lauderdale, FL
- Aaron Cohen, M.D. Internal Medicine · Atlantis, FL
- Ferdinand J. Formoso, D.O. Pain Medicine · Jacksonville, FL
- Rishi Kakar, M.D. Psychiatry · Tamarac, FL
- Howard S. Koch, MD Internal Medicine · Sunrise, FL
- Edgardo Rodriguez-falche, MD Psychiatry · Orlando, FL
- Naveed S. Ummed, M.D Psychiatry · Johns Creek, GA
- James F. Carroll, M.D. Emergency Medicine · Springfield, MA
- Marc J. Fishman, M.D. Psychiatry · Baltimore, MD
- Vincent E. Rampersaud, MD Pain Medicine · Flint, MI
- Junaid M. Syed, M.D. Psychiatry · Saint Louis, MO
- Joseph A. Kwentus, MD Psychiatry · Flowood, MS
- Jamila R. Battle, M.D. Sleep Medicine · Raleigh, NC
- Rasheed A. Onafuye, M.D Psychiatry · Monroe, NC
- Mustafa M. Rawaf, DO Psychiatry · Las Vegas, NV
- Zinoviy Benzar, M.D. Psychiatry · Brooklyn, NY
- Alain H. Litwin, MD, MPH Addiction Medicine · Bronx, NY
- Leonardo Vando, MD Psychiatry · New York, NY
- Richard Sanders Psychiatry · Dayton, OH
- Marvin L. Peyton, M.D. Psychiatry · Oklahoma City, OK
- Gita -. Pujari II, M.D. Addiction Medicine · Oklahoma City, OK
- Robert M. Westcott, M.D. Family Medicine · Lindsay, OK
- Daniel Gruener, M.D. Pain Medicine · Philadelphia, PA
- Jorge N. Avila, M.D. Psychiatry · El Paso, TX
- Dominick S. D'aunno, MD Internal Medicine · Houston, TX
- Rajinder Shiwach, MD Psychiatry · Desoto, TX
- Jason L. Andersen, DO Psychiatry · Provo, UT
- Scott Erickson Family Medicine · Bountiful, UT
- Michael S. Roundy, PHYSICIAN SURGEON Psychiatry · Bountiful, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Imagine Research of Florida DBA Imagine Research of PAlm Beach County $2.3M
- Clinical Research of Broward County DBA Clinical Research Center of Florida LLC $2.1M
- Pahl Pharmaceutical Professionals LLC $579,315
- Boeson Research LLC $461,394
- Artemis Headlands LLC $438,365
- Quantum Clinical Trials LLC $434,590
- Prisma Health Greer Memorial Hospital, SC $368,920
- Unity Clinical Research LLC $331,035
- Progressive Clinical Research LLC $323,330
- Alpine Research Organization Inc $295,004
- Vitalix Clinical Inc $290,685
- Boyett Health Services $282,770
- Insite Clinical Research LLC $273,877
- Monroe Biomedical Research LLC $208,756
- Annex Clinical Corporation $197,213
- Maryland Treatment Center $192,005
- Erg - Midwest Clinical Research Center LLC $137,235
- Oasis Clinical Trials $120,002
- Sandhill Research $114,365
- Imagine Res of PAlm Beach Cty $89,391
- Formoso PAin Specialists PA DBA Bold City Clinical Research $87,076
- West Clinical Research $76,627
- Sp Research PLLC DBA Rivus Wellness and Research Institute $72,404
- Vitalix Kissimmee LLC $66,637
- Clinical Research Center of Florida $66,116
- Innovative Clinical Research Inc $63,667
- Elite Clinical Studies LLC $62,739
- Hd Research LLC Co Erg Holding Company LLC $37,203
- Insight Research Institute $34,280
- El PAso Clinical Trials $34,229
- Precise Clinical Research Inc $33,198
- Ima Evaluations LLC DBA Ima Clinical Research $24,575
- Arch Clinical Trials LLC $21,200
- Agile Clinical Research Trials LLC $20,800
- Boeson Research Pvu $20,288
- Pahl Pharmaceutical Professionals $19,069
- Imagine Research of PAlm Beach County $16,944
- Boyett Health Services Inc $16,239
- Quantum Clinical Trials $15,453
- Prisma Health Addiction $14,166
- Empire Clinical Research $13,600
- Dr Vando Medical Services $12,704
- Annex Clinical Corporation on Behalf of Dr Vando Medical Services $12,163
- Vitalix Clinical $12,016
- Bold City Clin Res $10,019
- Insite Clinical Research $9,987
- Progressive Clinical Res LLC $8,481
- Artemis Inst for Clin Res $8,124
- North County Clinical Research Inc $7,178
- Unity Clinical Research $6,627
- Alpine Research Organization $6,485
- Vitalix Kissimmee $5,717
- Oasis Clinical Research $5,469
- Midwest Clinical Research Center $4,215
- Precise Clinical Research $3,713
- Rivus Wellness & Research Institute $2,829
- Richmond Behavioral Assoc $2,708
- Elite Clinical Trials $2,708
- Arch Clinical Trials $2,708
- Monroe Biomedical Research $2,119
- Accel Res Sites $514
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.