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Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02357901
First Posted: February 6, 2015
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indivior Inc.
  Purpose
This is a randomized, double-blind, placebo controlled, multisite study in male and female participants who are seeking treatment for opioid use disorder.

Condition Intervention Phase
Opioid Dependence Opioid Related Disorders Drug: Sublingual Film buprenorphine Drug: RBP-6000 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Efficacy of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP 6000) Over 24 Weeks in Treatment-Seeking Participants With Opioid Use Disorder

Resource links provided by NLM:


Further study details as provided by Indivior Inc.:

Primary Outcome Measures:
  • Cumulative distribution function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined with Self-Reports Negative for Illicit Opioid Use Collected from Week 5 through Week 24 [ Time Frame: Weeks 5-24 ]

Secondary Outcome Measures:
  • Percentage of Participants Considered Responders from Week 5 - Week 24 [ Time Frame: Weeks 5-24 ]
    Treatment success is defined as ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use between weeks 5-24.

  • Cumulative distribution function (CDF) of the Percentage of Urine Samples Negative for Opioids Collected from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Cumulative distribution function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Collected from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Change from Baseline in the Opioid Craving Score using the Opioid Craving Visual Analog Scale (VAS) from Week 5 through Week 24 [ Time Frame: Day -1 (baseline), Weeks 5-24 ]
  • Percentage of Participants Who Complete the Week 24 Visit ("Completers") [ Time Frame: Week 24 ]
  • Percentage of Subjects who are abstinent [ Time Frame: Week 24 ]
    Subjects With Both a Negative Urine Sample and Negative Self-Report for Illicit Opioid Use at Week 24

  • Mean Score on the Clinical Global Impression - Improvement Scale (CGI-I) from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Mean Score on the Clinical Global Impression - Severity Scale (CGI-S) from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Total score on the Clinical Opiate Withdrawal Scale (COWS) from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Total score on the Subjective Opiate Withdrawal Scale (SOWS) from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Total Number of Weeks of Abstinence as Assessed from Urine Samples Negative for Opioids Combined with Self-Reports Negative for Illicit Opioid Use Collected from Week 5 through Week 24 [ Time Frame: Weeks 5 through 24 ]
  • Participants with Adverse Events [ Time Frame: Day 1 through Week 24 ]
  • Injection Site Pain as Measured by Participant-Reported Visual Analog Scale (VAS) [ Time Frame: Day 1 through Week 24 ]
  • Suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 1 through Week 24 ]

Enrollment: 505
Actual Study Start Date: January 28, 2015
Study Completion Date: April 29, 2016
Primary Completion Date: April 29, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose RBP-6000
Participants are initially inducted onto Sublingual Film buprenorphine for 3-14 days at dosages ranging from 2-24 mg until there is no significant craving or withdrawal reported. Participants are then randomized. Participants in this treatment arm are given RBP-6000 high dose injections on Days 1 and 29. Injections 3-6 are separated by 28 days (Day 57-Day 141) and contain RBP-6000 high dose
Drug: Sublingual Film buprenorphine
Sublingual film is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization
Other Names:
  • buprenorphine
  • Sublingual Film
  • SUBOXONE
Drug: RBP-6000
Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either High dose or Low dose
Other Names:
  • Buprenorphine
  • Sublingual Film
Experimental: Low Dose RBP-6000
Participants are initially inducted onto sublingual film buprenorphine for 3-14 days at dosages ranging from 2-24 mg until there is no significant craving or withdrawal reported. Participants are then randomized. Participants in this treatment arm are given high dose injections of RBP-6000 on Days 1 and 29. Injections 3-6 are separated by 28 days (Day 57-Day 141) and contain RBP-6000 low dose.
Drug: Sublingual Film buprenorphine
Sublingual film is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization
Other Names:
  • buprenorphine
  • Sublingual Film
  • SUBOXONE
Drug: RBP-6000
Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either High dose or Low dose
Other Names:
  • Buprenorphine
  • Sublingual Film
Placebo Comparator: Placebo matching High dose of RBP-6000
Participants are initially inducted onto sublingual film buprenorphine for 3-14 days at dosages ranging from 2-24 mg until there is no significant craving or withdrawal reported. Participants are then randomized. Participants in this treatment arm are given placebo injections matching the high dose of RBP-6000 on Days 1 and 29. Injections 3-6 are separated by 28 days (Day 57-Day 141) and contain placebo matching the volume of RBP-6000 High dose.
Drug: Sublingual Film buprenorphine
Sublingual film is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization
Other Names:
  • buprenorphine
  • Sublingual Film
  • SUBOXONE
Drug: Placebo
Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen expect volumes matching the experimental drug at either the Low dose or High dose
Other Name: Matching placebo
Placebo Comparator: Placebo matching Low dose RBP-6000
Participants are initially inducted onto sublingual film buprenorphine for 3-14 days at dosages ranging from 2-24 mg until there is no significant craving or withdrawal reported. Participants are then randomized. Participants in this treatment arm are given placebo injections matching the volume of RBP-6000 High dose on Days 1 and 29. Injections 3-6 are separated by 28 days (Day 57-Day 141) and contain placebo matching the volume of RBP-6000 Low dose.
Drug: Sublingual Film buprenorphine
Sublingual film is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization
Other Names:
  • buprenorphine
  • Sublingual Film
  • SUBOXONE
Drug: Placebo
Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen expect volumes matching the experimental drug at either the Low dose or High dose
Other Name: Matching placebo

Detailed Description:
Participants will be inducted with sublingual film strip. This is a 24-week non-residential study with participants being randomized after meeting criteria. On Day 1 and Day 29 (± 2 days) participants will receive subcutaneous injections of high dose or placebo. Thereafter, participants will receive 4 injections (once every 28 days ± 2 days) of high or low doses or placebo.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder
  • By medical history has met DSM-5 criteria for moderate or severe opioid use disorder for the 3 months immediately prior to signing the informed consent form
  • Is seeking medication-assisted treatment for opioid use disorder
  • Is an appropriate candidate for opioid partial-agonist medication-assisted treatment in the opinion of the Investigator or medically responsible physician
  • Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m^2

Exclusion Criteria:

  • Current diagnosis other than opioid use disorder requiring chronic opioid treatment
  • Current substance use disorder as defined by DSM-5 criteria with regard to any substances other than opioids, cocaine, cannabis, tobacco, or alcohol.
  • Positive urine drug screen (UDS) result at screening for cocaine or cannabis AND meets DSM-5 criteria for either moderate or severe cocaine or cannabis use disorder, respectively
  • Meets DSM-5 criteria for moderate or severe alcohol use disorder
  • Received medication-assisted treatment for opioid use disorder (e.g., methadone, buprenorphine) in the 90 days prior to providing written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357901


  Show 38 Study Locations
Sponsors and Collaborators
Indivior Inc.
Investigators
Study Director: Director Global Clinical Development Reckitt Benckiser Pharmaceutical
  More Information

Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT02357901     History of Changes
Other Study ID Numbers: RB-US-13-0001
First Submitted: February 3, 2015
First Posted: February 6, 2015
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Opioid-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists