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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)

Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone. The maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Have a current mild, moderate or severe opioid use disorder (OUD)

• Are reliable and willing to make themselves available for the duration of the study (for example, are not incarcerated, not homeless) and attend required study visits, and are willing and able to follow study procedures as required, such as

‣ self-inject study intervention Note: Participants who are not able to perform the injections must have the assistance of a support person trained to administer the study intervention

⁃ store and use the provided study intervention as directed

⁃ maintain electronic or paper study diaries, as applicable, and

⁃ complete the required questionnaires

• Are intermittently using non-legal, non-prescribed opioids

• Are taking buprenorphine for treatment on OUD

Locations
United States
Arkansas
Pillar Clinical Research- Little Rock
NOT_YET_RECRUITING
Little Rock
Woodland International Research Group
RECRUITING
Little Rock
Arizona
NoesisPharma - Phoenix - East Shea Boulevard
RECRUITING
Phoenix
California
Ark Clinical Research - Fountain Valley
RECRUITING
Fountain Valley
Center on Substance Use and Health (CSUH)
NOT_YET_RECRUITING
San Francisco
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
RECRUITING
San Francisco
Florida
Bradenton Research Center, Inc.
RECRUITING
Bradenton
K2 Medical Research - Daytona Beach
RECRUITING
Daytona Beach
NextPhase Research Florida - Hollywood
RECRUITING
Hollywood
Accel Research Sites - Lakeland Clinical Research Unit
RECRUITING
Lakeland
Life Arc Research Centers - Miami
RECRUITING
Miami
Advanced Research for Health Improvement, LLC
RECRUITING
Naples
Innovative Research Institute - Port Charlotte
NOT_YET_RECRUITING
Port Charlotte
Better Years Ahead Medical Center
RECRUITING
Tampa
Neuroscience Research Institute - West Palm Beach
RECRUITING
West Palm Beach
Illinois
Re:Cognition Health - Chicago
RECRUITING
Chicago
Indiana
Indiana University Health Neuroscience Center
RECRUITING
Indianapolis
Kentucky
University of Kentucky Chandler Medical Center
NOT_YET_RECRUITING
Lexington
Massachusetts
Adams Clinical Boston
RECRUITING
Boston
Boston Medical Center
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Adams Clinical Watertown
RECRUITING
Watertown
Maryland
Maryland Treatment Centers - Mountain Manor Treatment Center
RECRUITING
Baltimore
Maryland Treatment Centers - Avery Road Treatment Center
NOT_YET_RECRUITING
Rockville
Mississippi
SKY Integrative Medical Center/SKYCRNG
RECRUITING
Ridgeland
New York
Adams Clinical Harlem
RECRUITING
New York
Adams Clinical Bronx
RECRUITING
The Bronx
Ohio
Ohio Clinical Trials
RECRUITING
Columbus
Oklahoma
Rivus Wellness and Research Institute
SUSPENDED
Oklahoma City
Pennsylvania
Adams Clinical Philadelphia
RECRUITING
Philadelphia
Penn Medicine: University of Pennsylvania Health System
NOT_YET_RECRUITING
Philadelphia
Rhode Island
Brown University School of Public Health
RECRUITING
Providence
South Dakota
Avera Research Institute - Sioux Falls
RECRUITING
Sioux Falls
Texas
Adams Clinical Dallas
RECRUITING
Desoto
Biopharma Informatic, LLC
RECRUITING
Houston
Virginia
University of Virginia Health System
NOT_YET_RECRUITING
Charlottesville
Carilion Clinic
NOT_YET_RECRUITING
Roanoke
Washington
University of Washington - Harborview Medical Center
RECRUITING
Seattle
Other Locations
Canada
CaRe Clinic
NOT_YET_RECRUITING
Calgary
Med Trust Research
RECRUITING
Courtice
Kelowna Health and Memory Centre
NOT_YET_RECRUITING
Kelowna
Providence Care
NOT_YET_RECRUITING
Kingston
Malton Medical Group
RECRUITING
Mississauga
Centre for Addiction and Mental Health (CAMH)
NOT_YET_RECRUITING
Toronto
Comprehensive Treatment Clinic
RECRUITING
Toronto
Gordon and Leslie Diamond Health Care Centre
NOT_YET_RECRUITING
Vancouver
Puerto Rico
Research Works San Juan
NOT_YET_RECRUITING
Guaynabo
United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
NOT_YET_RECRUITING
Chertsey
Queen Elizabeth University Hospital
NOT_YET_RECRUITING
Glasgow
Bioluminux - London
NOT_YET_RECRUITING
London
Lambeth Drug and Alcohol Treatment Consortium
NOT_YET_RECRUITING
London
St Pancras Clinical Research
NOT_YET_RECRUITING
London
Bioluminux Clinical Research - Milton Keynes
NOT_YET_RECRUITING
Milton Keynes
Salford Royal Hospital
NOT_YET_RECRUITING
Salford
Bioluminux - Southampton
NOT_YET_RECRUITING
Southampton
Old Bank House Hillingdon Drug & Alcohol
NOT_YET_RECRUITING
Uxbridge
Bioluminux - Wolverhampton
NOT_YET_RECRUITING
Wolverhampton
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
1-317-615-4559
Time Frame
Start Date: 2026-03-12
Estimated Completion Date: 2028-02
Participants
Target number of participants: 465
Treatments
Experimental: Part A and Part B: Brenipatide + Buprenorphine Dose 1
Part A: Brenipatide administered subcutaneously (SC) + Buprenorphine administered sublingual or buccal.~Part B: Open-label Treatment: Participants will receive Brenipatide SC + Buprenorphine sublingual or buccal.
Experimental: Part A: Brenipatide + Buprenorphine Dose 2
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
Experimental: Part A: Brenipatide + Buprenorphine Dose 3
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
Placebo_comparator: Part A: Placebo + Buprenorphine
Placebo administered SC + Buprenorphine administered sublingual or buccal.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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