Clinical trial NCT03604159: XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Official title: Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependence
Keywords: Opioid dependence
Buprenorphine
primary care treatment
extended-release buprenorphine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: New York City Health and Hospitals Corporation
First posted: 2018-07-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8
timeFrame: 8 Weeks
measure: # of Participants Retained on Their Randomly Assigned Treatment at Week 8
timeFrame: 8 weeks
measure: Mean # of Weeks (0-8) on Any Buprenorphine Treatment
timeFrame: 8 weeks
measure: Urine Samples Opioid-negative
timeFrame: 8 weeks
measure: the # of Participants Re-incarcerated
timeFrame: 8 weeks
measure: The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
timeFrame: Post-randomization and pre-release, (0-3 months)
Secondary outcomes:
measure: The # of Participants That Received Their Randomly Assigned Study Medication
timeFrame: 8 Weeks
measure: The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
timeFrame: 0-3 months (pre-release)
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Joshua D Lee, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.