XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

• ClinicalTrials.gov Identifier: NCT03604159
• Recruitment Status: Completed
• First Posted: July 27, 2018
• Results First Posted: January 11, 2022
• Last Update Posted: January 11, 2022
• Sponsor: NYU Langone Health
• Collaborator: NYC Health + Hospitals
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.

Condition or disease	Intervention/treatment	Phase
Opioid Dependence	Drug: Buprenorphine Extended Release; Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone
• Actual Study Start Date: June 24, 2019
• Actual Primary Completion Date: May 4, 2020
• Actual Study Completion Date: May 4, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Buprenorphine Extended-Release; XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.	Drug: Buprenorphine Extended Release; XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.; Other Name: SUBLOCADE
Active Comparator: Sublingual Buprenorphine; SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.	Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets); SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.

Outcome Measures

Primary Outcome Measures :

1. # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 [ Time Frame: 8 Weeks ]
   Retained on any form of community buprenorphine treatment at Week 8
2. # of Participants Retained on Their Randomly Assigned Treatment at Week 8 [ Time Frame: 8 weeks ]
   Retained on assigned treatment at Week 8
3. Mean # of Weeks (0-8) on Any Buprenorphine Treatment [ Time Frame: 8 weeks ]
   Weeks (0-8) on buprenorphine treatment, mean (SD)
4. Urine Samples Opioid-negative [ Time Frame: 8 weeks ]
   number of opioid-negative urine samples
5. the # of Participants Re-incarcerated [ Time Frame: 8 weeks ]
   Re-incarceration
6. The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication [ Time Frame: Post-randomization and pre-release, (0-3 months) ]
   Jail medical clinic visits per day following study medication induciton, mean

Secondary Outcome Measures :

1. The # of Participants That Received Their Randomly Assigned Study Medication [ Time Frame: 8 Weeks ]
   Received assigned study medication
2. The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled [ Time Frame: 0-3 months (pre-release) ]
   Received assigned study medication prior to release as scheduled

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Adults >18yo incarcerated in NYC jails with known release dates.
• DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
• Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.

Exclusion Criteria:

• Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.
• Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant
• No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.

Contacts and Locations

Locations

United States, New York

Bellevue Hospital Center

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

NYC Health + Hospitals

Investigators

• Principal Investigator: Joshua D Lee, MD, MSc; NYU School of Medicine

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol and Statistical Analysis Plan  [PDF] December 11, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cheng A, Badolato R, Segoshi A, McDonald R, Malone M, Vasudevan K, Badiei B, Sugarman A, Macdonald R, Mangat J, Giftos J, Lee JD, Tofighi B. Perceptions and experiences toward extended-release buprenorphine among persons leaving jail with opioid use disorders before and during COVID-19: an in-depth qualitative study. Addict Sci Clin Pract. 2022 Jan 29;17(1):4. doi: 10.1186/s13722-022-00288-4.

Lee JD, Malone M, McDonald R, Cheng A, Vasudevan K, Tofighi B, Garment A, Porter B, Goldfeld KS, Matteo M, Mangat J, Katyal M, Giftos J, MacDonald R. Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail. JAMA Netw Open. 2021 Sep 1;4(9):e2123032. doi: 10.1001/jamanetworkopen.2021.23032.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03604159
• Other Study ID Numbers: 18-00823
• First Posted: July 27, 2018
• Results First Posted: January 11, 2022
• Last Update Posted: January 11, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• Time Frame: To achieve aims in the approved proposal.
• Access Criteria: Researchers who provide a methodologically sound proposal.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by NYU Langone Health:

Opioid dependence; Buprenorphine; primary care treatment; extended-release buprenorphine

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists