Expired Study
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Overland Park, Kansas 66212


Purpose:

This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.


Criteria:

Inclusion Criteria: - Currently meets DSM-5 criteria for moderate or severe opioid use disorder (OUD) - Is seeking treatment for OUD - Body mass index: ≥ 18.0 to ≤ 35.0 kg/m^2 - Females: Female individuals of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum 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: Male individuals with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the informed consent form through at least 6 months after the last dose of IMP. Male individuals must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP. - Have a normal electrocardiogram (ECG) or ECG with no clinically significant findings in the opinion of the Investigator or medically qualified sub-investigator at Screening and through pre-dose on Day 1. - Agree not to take any buprenorphine-containing products, other than those administered for the current study, throughout the duration of the study. - Willing to adhere to study procedures and provide written informed consent prior to start of any study procedures. Exclusion Criteria: - Current diagnosis, other than OUD, requiring chronic opioid treatment. - Pregnant or lactating females. - Have an ECG demonstrating a corrected QT interval using Fridericia's calculation (QTcF) > 450 msec in males and QTcF > 470 msec in females upon admission to the residential facility or prior to administration of RBP-6000. - Currently meet the criteria for diagnosis of moderate or severe substance use disorder, by DSM-5 criteria, for any substances other than opioids, and/or tobacco. - Had a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form. - Used buprenorphine-containing products within the 14 days prior to signing the informed consent form. - Have a history of suicidal ideation within the 30 days prior to signing the informed consent form or prior to study drug administration - Have a history or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, naloxone, methadone, or the ATRIGEL Delivery System. - Individuals who have a positive urine drug screen (UDS) prior to admission to the residential facility for barbiturates, benzodiazepines, buprenorphine, or methadone.


NCT ID:

NCT02559973


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Overland Park, Kansas 66212
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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