Opioid Use Disorder Clinical Trial
Official title:
A Multiple-Dose Study of Blockade of Subjective Opioid Effects, Plasma Levels, and Safety of Subcutaneous Injections of Depot Buprenorphine (RBP-6000) in Subjects With Opioid Use Disorder
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate
to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of
Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the
effects of exogenous opioids.
The primary objective of this study was to demonstrate that the "Drug Liking" visual analog
scale (VAS) measured after challenge with 6 mg (Dose 1) and 18 mg (Dose 2) hydromorphone was
noninferior to the "Drug Liking" visual analog scale (VAS) measured after challenge with
placebo at Weeks 1-4 post first injection of subcutaneous buprenorphine 300 mg (RBP-6000).
For the hydromorphone challenge testing, subjects were randomized and assigned to 1 of 6
sequences during each week of hydromorphone challenge sessions.
On Day -18, subjects who met initial eligibility criteria were admitted to the clinical
facility for the baseline hydromorphone challenge. If the subject had acceptable
hydromorphone responses to the hydromorphone challenge, they remained confined to the
clinical facility for induction on SUBOXONE sublingual film. Once it was confirmed that a
subject was experiencing opioid withdrawal, as evidenced by a Clinical Opiate Withdrawal
Scale (COWS) score greater than 12, the subject was inducted on SUBOXONE sublingual film.
Multiple doses were allowed while subjects were reaching a stable dose until Day -9 when
subjects were stabilized on a dose of SUBOXONE 8 mg - 24 mg. SUBOXONE sublingual film was
administered daily at approximately the same time of day (± 1 hour) once the dose was
stabilised. There was a hydromorphone challenge conducted on days -3 to -1. The last day of
SUBOXONE dosing was day -1.
On Day 1, participants who met all inclusion/exclusion criteria and dosing criteria stopped
receiving SUBOXONE sublingual film and received Injection 1 of RBP-6000 containing 300 mg
buprenorphine. Participants returned in the evening of Days 4, 11, 18, and 25 to begin
inpatient stays of 3 consecutive days (starting with Days 4-7 [and equivalent for subsequent
weeks]). During these inpatient visits, subjects underwent randomised hydromorphone
challenges, PK sample collection, Reinforcing Effects Tasks, and safety assessments.
On Day 29, participants received the second injection of RBP-6000 containing 300 mg
buprenorphine (Injection 2). Participants returned in the evening on Days 32, 39, 46, 53, 60,
67, 74, and 81 to begin inpatient states of 3 consecutive days (starting with days 32-35 [and
equivalent for subsequent weeks]). During these inpatient visits, subjects underwent
randomised hydromorphone challenges, pharmacokinetic (PK) samples collection, Reinforcing
Effects Tasks, and safety assessments. A window of ± 1 day was allowed for all visits, except
the Day 53-56 visit, which was required by the protocol to be completed on those days.
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