Clinical trial NCT02510014: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
Official title: An Open-Label, Long-Term Safety and Tolerability Study of Depot Buprenorphine (RBP-6000) in Treatment-Seeking Subjects With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use Disorder
Opioid-related Disorders
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-28
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
timeFrame: Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)
measure: Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs
timeFrame: Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
measure: Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period
timeFrame: Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
measure: Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)
timeFrame: 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:
measure: Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)
timeFrame: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
measure: Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)
timeFrame: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
measure: Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)
timeFrame: Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)
measure: Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)
timeFrame: 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
Other outcomes:
Locations:
city: Haleyville
country: United States
facility: Haleyville Clinical Research
state: Alabama
city: Hamilton
country: United States
facility: Boyett Health Services
state: Alabama
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Jacksonville
country: United States
facility: Amit Vijapura
state: Florida
city: Lake City
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Maitland
country: United States
facility: Try Research
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Prairie Village
country: United States
facility: Phoenix Medical Research
state: Kansas
city: New Orleans
country: United States
facility: Louisiana Research Associates
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers, Inc.
state: Mississippi
city: Saint Louis
country: United States
facility: St Louis Clinical Trials
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Canton
country: United States
facility: Neuro-behavioral Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals
state: Oklahoma
city: Portland
country: United States
facility: CODA
state: Oregon
city: Altoona
country: United States
facility: Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPenn Treatment Research Center
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials
state: South Carolina
city: Dallas
country: United States
facility: Pillar Clinical Research
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
Study officials:
affiliation: Indivior Inc.
name: Global Director Clinical Development
role: STUDY_DIRECTOR
References:
citation: 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.