Clinical trial NCT02559973: Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
Official title: A Single-Center, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine (RBP-6000) Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) in Comparison to Intermediate Molecular Weight (Reference Treatment) in Treatment-Seeking Subjects With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Use Disorder
Keywords: Buprenorphine
opioid use disorder
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
timeFrame: Day 1 to Day 29
measure: Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
timeFrame: Day 1 to Day 57
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine
timeFrame: Day 1 to Day 29
measure: Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine
timeFrame: Day 1 to Day 57
measure: Participants with Treatment-Emergent Adverse Events
timeFrame: Day 1 to Day 57
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research
state: Kansas
Study officials:
References: