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Opioid Use DisorderPhase 3NCT02510014

Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

A Phase 3 study testing SUBOXONE sublingual film and RBP-6000 in people with Opioid Use Disorder and Opioid-related Disorders, run by Indivior Inc. at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Use Disorder, Opioid-related Disorders
What is being tested?
SUBOXONE sublingual film and RBP-6000
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
775 participants
Where
42 sitesUnited States
Study dates
27 Jul 2015to 31 Jan 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • De novo subjects:
  • Seeking treatment for opioid use disorder (OUD) and for the previous 3 months meet the Diagnostic and Statistical Manual 5 (DSM-5) criteria for moderate or severe OUD
  • Appropriate candidate for opioid partial-agonist treatment
  • BMI between 18 and 35, inclusive
  • Roll-over subjects:
  • Completed RB-US-13-0001

Who cannot join

  • De novo subjects:
  • Current diagnosis, other than OUD, requiring chronic opioid treatment
  • Current substance use disorder with regard to substances other than opioids, cocaine, cannabis, tobacco or alcohol
  • Received medication-assisted treatment for OUD in the 90 days prior to informed consent
  • Use (within past 30 days prior to informed consent) or positive urine drug screen (UDS) at screening for barbiturates, benzodiazepines,methadone or buprenorphine
  • Treatment for OUD required by court order
Show all 10Show fewer
  • History of recent suicidal ideation or attempt
  • Roll over subjects:
  • Experienced major protocol deviations or adverse events in RB-US-13-0001 which could potentially compromise subject safety
  • Discontinued early from study RB-US-13-0001

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Atlanta Institute of Medicine and Research

    Alpharetta, Georgia, 30005

  • Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA

    Altoona, Pennsylvania, 16602

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Neuro-behavioral Clinical Research

    Canton, Ohio, 44718

  • Carolina Clinical Trials

    Charleston, South Carolina, 29407

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Pillar Clinical Research

    Dallas, Texas, 75243

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Stanley Street Treatment and Resources

    Fall River, Massachusetts, 02720

  • Precise Research Centers, Inc.

    Flowood, Mississippi, 39232

  • Collaborative Neuroscience Network

    Garden Grove, California, 92845

  • Charak Clinical Research Center

    Garfield Heights, Ohio, 44125

  • Behavioral Research Specialists

    Glendale, California, 91206

  • Haleyville Clinical Research

    Haleyville, Alabama, 35565

  • Boyett Health Services

    Hamilton, Alabama, 35570

  • Amit Vijapura

    Jacksonville, Florida, 32256

  • Sarkis Clinical Trials

    Lake City, Florida, 32025

  • Meridien Research

    Lakeland, Florida, 33805

  • Altea Research

    Las Vegas, Nevada, 89102

  • Innovative Clinical Research

    Lauderhill, Florida, 33319

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Florida Clinical Research Center

    Maitland, Florida, 32751

  • Try Research

    Maitland, Florida, 32751

  • Synergy Clinical Research Center

    National City, California, 91950

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Scientific Clinical Research

    North Miami, Florida, 33161

  • Pacific Research Partners

    Oakland, California, 94612

  • Research Centers of America

    Oakland Park, Florida, 33334

  • North County Clinical Research

    Oceanside, California, 92056

  • Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma, 73112

  • Pahl Pharmaceutical Professionals

    Oklahoma City, Oklahoma, 73112

  • Neuropsychiatric Research Center of Orange County

    Orange, California, 92868

  • Aspen Clinical Research, LLC

    Orem, Utah, 84058

  • UPenn Treatment Research Center

    Philadelphia, Pennsylvania, 19104

  • CODA

    Portland, Oregon, 97214

  • Phoenix Medical Research

    Prairie Village, Kansas, 66206

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Louisiana Clinical Research

    Shreveport, Louisiana, 71101

  • St Louis Clinical Trials

    St Louis, Missouri, 63141

  • Adams Clinical Trials

    Watertown, Massachusetts, 02472

Other trials in United States

About this study

Official title: An Open-Label, Long-Term Safety and Tolerability Study of Depot Buprenorphine (RBP-6000) in Treatment-Seeking Subjects With Opioid Use Disorder

A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.

Read the detailed description

Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately 300 subjects who completed the randomized,double-blind, placebo-controlled study NCT02357901 (RB-US-13-0001) ('roll-over' participants), and approximately 300 subjects who did not participate in study RB-US-13-0001 ('de novo' participants). Following informed consent and completion of screening procedures, all subjects will receive SUBOXONE sublingual film, titrated to response.

After 4-14 days of SUBOXONE sublingual film treatment, subjects will be evaluated for enrollment into the study. Eligible subjects will receive 300 mg RBP-6000 as an initial dose, followed by monthly injections of 100 mg or 300 mg RBP-6000, based on the medical judgment of the investigator.

Subjects who participated in study RB-US-13-0001 ('roll-over' participants) will receive monthly injections for up to 6 months. Subjects who did not participate in study RB-US-13-0001 ('de novo' participants) will receive monthly injections for up to12 months.

At all injection visits continuous electrocardiogram recordings and pulse oximetry will be collected prior to injection and at least 4 hours after injection. Subjects will return to the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event and injection site assessments.

Being tested
SUBOXONE sublingual film, RBP-6000
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUBOXONE sublingual filmDrug

    Also called SUBOXONE, buprenorphine

    SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.

  • RBP-6000Drug

    Also called Atrigel buprenorphine

    Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.

Study groups in NCT02510014
Study groupRoleWhat they receive
Roll-over SubjectsExperimentalSubjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.
Receives: Drug: SUBOXONE sublingual film; Drug: RBP-6000
De Novo SubjectsExperimentalSubjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.
Receives: Drug: SUBOXONE sublingual film; Drug: RBP-6000

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period

    TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.

    Measured: Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)

  2. Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs

    Vital signs include

    • systolic blood pressure (mmHg)
    • diastolic blood pressure (mmHg)
    • respiratory rate (breaths/minute)
    • weight (kg)
    • body mass index (kg/m^2)
    • waist-to-hip ratio

    Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1.

    Measured: Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)

  3. Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period

    The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation.

    C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study.

    Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'.

    Measured: Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)

  4. Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)

    Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.

    The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.

    Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented.

    De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309.

    Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141.

    Measured: De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141

Secondary outcomes (4)

  1. Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)

    COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.

    Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values.

    Measured: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)

  2. Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)

    The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.

    Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values.

    Measured: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)

  3. Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)

    The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids.

    Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values.

    Measured: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)

  4. Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)

    Participants' self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB.

    Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative.

    Measured: Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2015 (estimated)
  2. Study start27 Jul 2015
  3. Primary completion31 Jan 2017
  4. Study completion31 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
775 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02510014
Sponsor's protocol ID
RB-US-13-0003
Status last verified
Mar 2018
First submitted
20 Jul 2015
Last updated
29 Mar 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rutrick D, Learned SM, Boyett B, Hassman D, Shinde S, Zhao Y. 18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. J Subst Use Addict Treat. 2023 Nov;154:209155. doi: 10.1016/j.josat.2023.209155. Epub 2023 Aug 30.

    PubMed 37657559

  • Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.

    PubMed 35287034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SUBOXONE sublingual film and RBP-6000 in people with Opioid Use Disorder and Opioid-related Disorders, run by Indivior Inc. at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period (time frame: Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02510014, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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