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

• Buprenorphine Extended Release (Drug), also known as SUBLOCADE: 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) (Drug): 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.

Primary outcomes

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

Secondary outcomes

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

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

Participant flow

Outcome results

• # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 (Primary), Count of participants, Participants: Buprenorphine Extended-Release 18; Sublingual Buprenorphine 9
• # of Participants Retained on Their Randomly Assigned Treatment at Week 8 (Primary), Count of participants, Participants: Buprenorphine Extended-Release 15; Sublingual Buprenorphine 9
• Mean # of Weeks (0-8) on Any Buprenorphine Treatment (Primary), Mean, weeks: Buprenorphine Extended-Release 6.1 +/- 3.5; Sublingual Buprenorphine 2.6 +/- 3.2
• Urine Samples Opioid-negative (Primary), Number, urine samples: Buprenorphine Extended-Release 72; Sublingual Buprenorphine 50
• the # of Participants Re-incarcerated (Primary), Count of participants, Participants: Buprenorphine Extended-Release 2; Sublingual Buprenorphine 4
• The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication (Primary), Mean, jail clinic visits per day: Buprenorphine Extended-Release 0.11 (.05 to 0.16); Sublingual Buprenorphine 1.06 (0.88 to 1.23)
• The # of Participants That Received Their Randomly Assigned Study Medication (Secondary), Count of participants, Participants: Buprenorphine Extended-Release 24; Sublingual Buprenorphine 26
• The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled (Secondary), Count of participants, Participants: Buprenorphine Extended-Release 21; Sublingual Buprenorphine 26

Adverse events

Time frame: 3 months

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 35093164
• Results publication: 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. PMID 34495340

• Study Protocol and Statistical Analysis Plan (PDF, 2019-12-11)

• Joshua D Lee, MD, MSc, Principal investigator, NYU School of Medicine