Clinical trial NCT02896296: Open-Label Treatment Extension Study
Official title: An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in 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: 2016-09-12
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.

Detailed description: This is a multi-center, open-label, RBP-6000 treatment extension study in which subjects who have completed the End of Study (EOS) procedures for study RB-US-13-0003 are eligible. EOS assessments completed at the RB-US-13-0003 EOS visit serve as part of the screening visit for this study. In addition, subjects were requested to complete a Columbia Suicide Severity Rating Scale (C-SSRS) baseline/screening survey and a medical history and height was obtained.

The informed consent may be shared with subjects up to 2 months prior to the RB-US-13-0003 EOS visit, however should not be signed until all assessments for the EOS visit have been completed.

On Day 1, eligible subjects receive a subcutaneous (SC) injection of RBP-6000 at a low or high dose based on the medical judgment of the investigator. After the injection, vital signs and the injection site were assessed. Prior to departing the site, subjects were also assessed for adverse events (AEs) and use of concomitant medications (ConMeds).

Subjects return to the site for monthly injection visits every 28 days (-2 / +7 days) for a total of up to 6 injections (participants were not required to complete all 6 injections). At each subsequent visit (Injections 2 through 6) the following procedures / assessments were performed : urine pregnancy test performed for all female subjects who are of childbearing potential before each injection; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; vital signs collected pre and post each injection; RBP-6000 injection, urine drug screen (UDS); C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; local injection site grading, subject self-assessment of injection site pain (Injection Site Pain Visual Analog Scale \[VAS\]), assessment for adverse events (AEs).

Laboratory tests (hematology, chemistry and urinalysis) may be requested by the Investigator on an ad-hoc basis in order to assess for AEs.

A subject's alternative treatment options were assessed at least two months before EOS at each visit.

At EOS or early termination (ET), the following assessments were performed: urine pregnancy test performed for all female subjects who are of childbearing potential; vital signs; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; UDS; C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; assessment for AEs; a brief physical exam; height and body weight were measured and a subject's body mass index (BMI) and waist-to-hip ratio calculated; laboratory tests (hematology, chemistry, urinalysis).

Subjects were to be contacted by telephone approximately 4 weeks after EOS/ET for a safety follow-up assessment of AEs and use of ConMeds.

Eligibility criteria: Inclusion Criteria:

1. Provide written consent to participate in this study.
2. Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).
3. Be considered eligible in the medical judgment of the Investigator.
4. 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 form (ICF)) must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 6 months after the last dose of investigational medicinal product (IMP).

   Males: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
5. Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.
6. Subjects must be willing to adhere to study procedures.

Exclusion Criteria:

1. Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
2. Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
3. History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF.
4. Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor.

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period
timeFrame: Day 1 up to Week 29
measure: Percentage Change From Baseline to Week 25 in Vital Signs
timeFrame: Day 1, Week 25
measure: Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values
timeFrame: Day 1 up to Week 25
Secondary outcomes:
Other outcomes:
Locations:
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: Long Beach
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Amit Vijapura
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research
state: Florida
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: Hassman Research Institute
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
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: Rakesh Ranjan MD & Associates, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research, PLLC
state: Oklahoma
city: Portland
country: United States
facility: CODA
state: Oregon
city: Altoona
country: United States
facility: Keystone Clinical Solutions
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
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.