Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who
complete the RB-US-13-0003 study and for whom a new treatment venue has not been identified.
Drug: Low dose RBP-6000
Drug: High dose RBP-6000
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02896296
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Provide written consent to participate in this study.
Completed the End of Study Visit for the RB-US-13-0003 study.
Be considered eligible in the medical judgment of the Investigator.
Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to ICF) must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 6 months after the last dose of investigational medicinal product (IMP). Males: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.
Subjects must be willing to adhere to study procedures.
Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 EOS, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the C-SSRS
"screening/baseline" or history of a suicide attempt (per the C-SSRS) in the 6 months prior to ICF.
Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or OTC and herbal supplements with the potential to prolong QTc as per section 6.10.1 within 28 days of Day 1.
All locations for NCT02896296
United States (29)
Boyett Health Services
Hamilton, Alabama, United States, 35570
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
Pacific Research Partners
Oakland, California, United States, 94612
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Jacksonville, Florida, United States, 32256
Lakeland, Florida, United States, 33805
Innovative Clinical Research
Lauderhill, Florida, United States, 33319
Scientific Clinical Research
North Miami, Florida, United States, 33161
Phoenix Medical Research
Prairie Village, Kansas, United States, 66206
Louisiana Research Associates
New Orleans, Louisiana, United States, 70114
Louisiana Clinical Research
Shreveport, Louisiana, United States, 71101
Stanley Street Treatment and Resources
Fall River, Massachusetts, United States, 02720
Adams Clinical Trials
Watertown, Massachusetts, United States, 02472
Precise Research Centers, Inc.
Flowood, Mississippi, United States, 39232
St Louis Clinical Trials
Saint Louis, Missouri, United States, 63141
Las Vegas, Nevada, United States, 89102
Hassman Research Institute
Berlin, New Jersey, United States, 08009
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
Neuro-behavioral Clinical Research
Canton, Ohio, United States, 44708
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
Charak Clinical Research Center
Garfield Heights, Ohio, United States, 44125
Pahl Pharmaceutical Professionals
Oklahoma City, Oklahoma, United States, 73112
SP Research, PLLC
Oklahoma City, Oklahoma, United States, 73112
Portland, Oregon, United States, 97232
Keystone Clinical Solutions
Altoona, Pennsylvania, United States, 16601
Carolina Clinical Trials
Charleston, South Carolina, United States, 29407
Pillar Clinical Research
Dallas, Texas, United States, 75243
InSite Clinical Research
DeSoto, Texas, United States, 75115
View full eligibility
Tris trial is registered with FDA with number: NCT02896296. The sponsor of the trial is Indivior Inc. and it is looking for 208 volunteers for the current phase.
Official trial title: An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder
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