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Trial record 55 of 186 for:    BUPRENORPHINE AND NALOXONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03604159
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : April 8, 2019
NYC Health + Hospitals
Information provided by (Responsible Party):
NYU Langone Health

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

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.

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.

Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

Secondary Outcome Measures :
  1. Treatment Retention [ Time Frame: 8 Weeks ]
    Estimate the effectiveness of XRB vs. SLB in improving rates of community treatment initiation/continuation post-release

  2. Clinical Effectiveness [ Time Frame: 8 Weeks ]
    Estimate the effectiveness of XRB vs. SLB in decreasing illicit opioid (e.g. heroin) use post-release.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03604159

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Contact: Mia Malone 6465013577
Contact: Ryan McDonald, MA 6465012541

Sponsors and Collaborators
NYU Langone Health
NYC Health + Hospitals
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Principal Investigator: Joshua D Lee, MD, MSc NYU School of Medicine

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Responsible Party: NYU Langone Health Identifier: NCT03604159     History of Changes
Other Study ID Numbers: 18-00823
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
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.

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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
primary care treatment
extended-release buprenorphine
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists