XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
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|ClinicalTrials.gov Identifier: NCT03604159|
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependence||Drug: Buprenorphine Extended Release Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
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.
- Initial Patient medication assisted therapy (MAT) preference and treatment acceptability measured via the ASILite (lifetime substance use and legal involvement) form. [ Time Frame: 8 Weeks ]Measure initial patient preferences and treatment acceptability using a modified ASILite questionnaire. Collects data regarding 7 functional domains: medical, employment/support, drug and alcohol use, legal, family history, family social relationships, and psychiatric problems. Its yields a severity score and a composite score. The composite scores are useful for summarizing changes in patient status, which can be used in treatment outcome studies.
- In-treatment patient satisfaction assessed using a brief open-ended interview administered by study staff [ Time Frame: 8 weeks ]In-patient treatment satisfaction to be measured throughout the active treatment phase of the study using data collected during open-ended interview
- In-treatment patient satisfaction assessed using the Treatment Retention form [ Time Frame: 8 weeks ]completion of the treatment retention form. Higher completion indicative of higher retention rate
- overall treatment satisfaction questionnaire. [ Time Frame: 8 weeks ]14 items across 4 domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items) and global satisfaction (3 items) of the medication over the previous 2-3 weeks or since patients last use. Item scores are summed to give 4 domain scores, which are in turn transformed to a scale of 0- 100.
- Rates of medication diversion in-jail and in-community [ Time Frame: 8 weeks ]Assessed using the open-ended interview questionnaire which contains items specifically detailing diversion practices and motivations.
- Initial patient medication assisted therapy (MAT) preference and treatment acceptability measured via the MAT History & Preference questionnaire. [ Time Frame: 8 weeks ]Measure initial patient preferences and treatment acceptability using the MAT History and Preference questionnaire.
- Treatment Retention [ Time Frame: 8 Weeks ]Estimate the effectiveness of XRB vs. SLB in improving rates of community treatment initiation/continuation post-release
- Clinical Effectiveness [ Time Frame: 8 Weeks ]Estimate the effectiveness of XRB vs. SLB in decreasing illicit opioid (e.g. heroin) use post-release.
- Naturalistic Comparative Effectiveness [ Time Frame: 8 Weeks ]Evaluate outcomes of XRB vs. SLB in the context of the XRNTX, ETAU, and Methadone outcomes accrued in the larger SOMATICS-XOR RCT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604159
|Contact: Mia Malonefirstname.lastname@example.org|
|Contact: Ryan McDonald, MA||6465012541||Ryan.Mcdonald@nyulangone.org|
|Principal Investigator:||Joshua D Lee, MD, MSc||NYU School of Medicine|