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Multiple Dose Study of Blockade of Opioid Effects of Injections of Buprenorphine in Participants With Opioid Disorder

Information source: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Use Disorder

Intervention: Buprenorphine (Drug); buprenorphine and naloxone (Drug); hydromorphone (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Reckitt Benckiser Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
Clinical Development Manager, Study Director, Affiliation: Indivior, Inc

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value

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)

Summary of Participants with Adverse Events

Correlation between the opioid blockade subjective effect when participants are asked "Do you feel any drug effect?" and simulated mu opioid receptor occupancy

Correlation between the opioid blockade subjective effect when participants are asked "Does the drug have any good effects?" and simulated mu opioid receptor occupancy

Correlation between the opioid blockade subjective effect when participants are asked "Do you like the drug?" and simulated mu opioid receptor occupancy

Correlation between the opioid blockade subjective effect when participants are asked "Do you feel sedated?" and simulated mu opioid receptor occupancy

Correlation between the opioid blockade subjective effect when participants are asked "How high are you right now?" and simulated mu opioid receptor occupancy

Correlation between the opioid blockade subjective effect when participants are asked "Does the drug have any bad effects?" and simulated mu opioid receptor occupancy

Detailed 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).

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Vince & Associates Clinical Research, Overland Park, Kansas 66212, United States
Additional Information

Starting date: November 2013
Last updated: August 7, 2015

Page last updated: August 23, 2015

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