AzTrials
AzTrials

Opioid DependencePhase 4NCT03604159

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

A Phase 4 study testing Buprenorphine Extended Release and Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) in people with Opioid Dependence, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Opioid Dependence
What is being tested?
Buprenorphine Extended Release and Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
24 Jun 2019to 4 May 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bellevue Hospital Center

    New York, New York, 10016

Other trials in United States

About this study

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

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.

Being tested
Buprenorphine Extended Release, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Keywords
Opioid dependence, Buprenorphine, primary care treatment, extended-release buprenorphine
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buprenorphine Extended ReleaseDrug

    Also called 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.

Study groups in NCT03604159
Study groupRoleWhat they receive
Buprenorphine Extended-ReleaseExperimentalXRB 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.
Receives: Drug: Buprenorphine Extended Release
Sublingual BuprenorphineActive comparatorSLB (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.
Receives: Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. # 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

    Measured: 8 Weeks

  2. # of Participants Retained on Their Randomly Assigned Treatment at Week 8

    Retained on assigned treatment at Week 8

    Measured: 8 weeks

  3. Mean # of Weeks (0-8) on Any Buprenorphine Treatment

    Weeks (0-8) on buprenorphine treatment, mean (SD)

    Measured: 8 weeks

  4. Urine Samples Opioid-negative

    number of opioid-negative urine samples

    Measured: 8 weeks

  5. the # of Participants Re-incarcerated

    Re-incarceration

    Measured: 8 weeks

  6. 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

    Measured: Post-randomization and pre-release, (0-3 months)

Secondary outcomes (2)

  1. The # of Participants That Received Their Randomly Assigned Study Medication

    Received assigned study medication

    Measured: 8 Weeks

  2. 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

    Measured: 0-3 months (pre-release)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start24 Jun 2019
  3. Primary completion4 May 2020
  4. Study completion4 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03604159
Sponsor's protocol ID
18-00823
Status last verified
Dec 2021
First submitted
5 Jul 2018
Last updated
11 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 35093164

  • 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.

    PubMed 34495340

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Buprenorphine Extended Release and Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) in people with Opioid Dependence, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 (time frame: 8 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03604159, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in