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

Opioid Dependence Clinical Trial

Official title:

Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604159
• Other study ID #: 18-00823
• Status: Completed
• Phase: Phase 4
• Start date: June 24, 2019
• Est. completion date: May 4, 2020

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	NYC Health + Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8	Retained on any form of community buprenorphine treatment at Week 8	8 Weeks
Primary	# of Participants Retained on Their Randomly Assigned Treatment at Week 8	Retained on assigned treatment at Week 8	8 weeks
Primary	Mean # of Weeks (0-8) on Any Buprenorphine Treatment	Weeks (0-8) on buprenorphine treatment, mean (SD)	8 weeks
Primary	Urine Samples Opioid-negative	number of opioid-negative urine samples	8 weeks
Primary	the # of Participants Re-incarcerated	Re-incarceration	8 weeks
Primary	The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication	Jail medical clinic visits per day following study medication induciton, mean	Post-randomization and pre-release, (0-3 months)
Secondary	The # of Participants That Received Their Randomly Assigned Study Medication	Received assigned study medication	8 Weeks
Secondary	The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled	Received assigned study medication prior to release as scheduled	0-3 months (pre-release)