pharmacokinetics, safety, and tolerability of depot buprenorphine at three different molecular weights in treatment-seeking subjects with opioid use disorder

Conditions: Opioid Use Disorder

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.

Keywords: buprenorphine opioid use disorder