Overview

This trial is active, not recruiting.

Condition opioid use disorder
Treatments buprenorphine, buprenorphine and naloxone, hydromorphone, placebo
Phase phase 2
Sponsor Reckitt Benckiser Pharmaceuticals Inc.
Start date November 2013
End date November 2014
Trial size 30 participants
Trial identifier NCT02044094, RB-US-13-0002

Summary

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 exogenous opioids.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
300-mg buprenorphine (RBP-6000) administered as a single subcutaneous injection on Days 1 and 29. RBP-6000 effectiveness is 'challenged' on three consecutive days each week of the 12 week treatment period by participants taking hydromorphone at 0 mg (placebo), 6 mg and 18 mg doses assigned in randomized order and then completing study assessments.
buprenorphine RBP-6000
A depot of buprenorphine 300 mg delivered using the ATRIGEL® Delivery System on study days 1 and 29. As the depot degrades, buprenorphine is released into the systemic circulation at a consistent rate over an approximately 28-day period.
buprenorphine and naloxone SUBOXONE®
Buprenorphine and naloxone (SUBOXONE® sublingual film) is given to participants on days -14 to day -1 (the SUBOXONE Film stabilization period) as soon as they start to experience withdrawal symptoms. SUBOXONE is initially administered several times daily until the stable dose of between 8 mg and 24 mg daily is established.
hydromorphone dihydromorphinone
Hydromorphone challenges are administered during the screening period (days -17 to -15), during the SUBOXONE film stabilization period (days -3 to -1), and weekly during the 12-week treatment period after administration of RBP-6000. Each challenge consists of 3 days during which participants are administered 0 mg (placebo), 6 mg and 18 mg hydromorphone via intramuscular injection daily in varying blinded sequences. Hydromorphone can also be earned during the Reinforcing effects tasks and up to the same randomized dose received in the hydromorphone challenge that morning can be earned (or money can be chosen).
placebo 0.45% normal saline
Placebo for hydromorphone administered via intramuscular injection during each challenge.

Primary Outcomes

Measure
Opioid Blockade Following Administration of 0, 6, or 18 mg Intramuscular (IM) Hydromorphone As Measured Using the Subjective Opioid Effects Rating for the Question "Do you like the drug?" Visual Analog Scale (VAS)
time frame: Weeks 1-12

Secondary Outcomes

Measure
Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value
time frame: Weeks 1-12 (during each 3-day challenge)
Relationship between plasma concentration and predicted mu opioid receptor occupancy of buprenorphine and both the blockade of the subjective effects of hydromorphone post injection of buprenorphine 300 mg (RBP-6000)
time frame: Weeks 1-12
Summary of Participants with Adverse Events
time frame: Day 1 to Week 12
Correlation between the opioid blockade subjective effect when participants are asked "Do you feel any drug effect?" and simulated mu opioid receptor occupancy
time frame: Weeks 1-12
Correlation between the opioid blockade subjective effect when participants are asked "Does the drug have any good effects?" and simulated mu opioid receptor occupancy
time frame: Weeks 1-12
Correlation between the opioid blockade subjective effect when participants are asked "Do you like the drug?" and simulated mu opioid receptor occupancy
time frame: Weeks 1-12
Correlation between the opioid blockade subjective effect when participants are asked "Do you feel sedated?" and simulated mu opioid receptor occupancy
time frame: Weeks 1-12
Correlation between the opioid blockade subjective effect when participants are asked "How high are you right now?" and simulated mu opioid receptor occupancy
time frame: Weeks 1-12
Correlation between the opioid blockade subjective effect when participants are asked "Does the drug have any bad effects?" and simulated mu opioid receptor occupancy
time frame: Weeks 1-12

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder at screening and are not seeking opioid use disorder treatment - Body mass index of >= 18.0 to <= 33.0 kg/m^2 - Females - women 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 negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of study drug - Male subjects with female partners of child-bearing potential must agree to use medically acceptable contraception from screening through at least 3 months after the last dose of study drug Exclusion Criteria: - Subjects with any current diagnosis requiring chronic opioid treatment - Subjects who currently meet the criteria for diagnosis of moderate or severe substance use disorder by DSM-5 criteria for any substances other than opioids, caffeine, or nicotine. - Subjects who have abused or used buprenorphine within 14 days prior to informed consent. Other protocol-defined criteria may apply.

Additional Information

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
Description A study of RBP-6000 300 mg administered via subcutaneous depot injections using the ATRIGEL Delivery System to determine whether there is a difference in the average score of subjective-effects questionnaires completed by study participants (using a visual analog scale (VAS)) after administering 6 mg or 18 mg hydromorphone compared to 0 mg hydromorphone (placebo) as an opioid blockade test (challenge).
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Reckitt Benckiser Pharmaceuticals Inc..