70 Participants Needed

Low-Dose Buprenorphine for Opioid Use Disorder

BT
Overseen ByBenjamin T Hayes, MD, MS, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking FDA-approved medications for opioid use disorder, like methadone, buprenorphine, or naltrexone, you must stop at least 14 days before joining the study.

What data supports the effectiveness of the drug buprenorphine-naloxone for opioid use disorder?

Research shows that buprenorphine-naloxone is effective in treating opioid use disorder, especially when used as part of a comprehensive treatment program. It helps improve treatment outcomes, although adherence to the medication can be a challenge.12345

Is low-dose buprenorphine generally safe for humans?

Buprenorphine, often combined with naloxone, is generally well tolerated and considered safe for treating opioid use disorder in adults and adolescents over 15 years old. While it has a potential for abuse similar to other opioids, its combination with naloxone helps reduce misuse, and adverse effects are usually mild and rare.16789

How is the drug Buprenorphine-naloxone unique for treating opioid use disorder?

Buprenorphine-naloxone is unique because it combines buprenorphine, which helps reduce cravings and withdrawal symptoms, with naloxone, which deters misuse by causing withdrawal symptoms if injected. This combination aims to improve treatment adherence and reduce the risk of misuse compared to other treatments.1381011

What is the purpose of this trial?

The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.

Research Team

BT

Benjamin T Hayes, MD, MS, MPH

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

Adults over 18 with opioid use disorder who are willing to follow study procedures and can take sublingual medication. They must not be pregnant, lactating, or have cognitive impairments that prevent consent. Participants should not be on other FDA-approved medications for opioid use disorder or have severe mental illness.

Inclusion Criteria

For participants of reproductive potential: agreement to use highly effective contraception during study participation
Provision of signed and dated informed consent form
Diagnosis of Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
See 3 more

Exclusion Criteria

Pregnancy or lactation
Severe untreated mental illness, meaning psychosis or suicidality
Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either an 8-day low-dose buprenorphine initiation protocol or treatment as usual, with study visits at baseline, week 2, and week 4.

8 days
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 2-week and 6-week visits.

6 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Buprenorphine-naloxone
Trial Overview The trial is testing the safety and effectiveness of starting treatment for opioid addiction with a low dose of buprenorphine-naloxone. The goal is to see if this approach helps people manage their condition better than current methods.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-dose initiationExperimental Treatment1 Intervention
Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose buprenorphine initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone. Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours
Group II: Treatment as usualActive Control1 Intervention
Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.

Buprenorphine-naloxone is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Suboxone for:
  • Opioid use disorder
🇪🇺
Approved in European Union as Suboxone for:
  • Opioid dependence
🇺🇸
Approved in United States as Zubsolv for:
  • Opioid use disorder
🇪🇺
Approved in European Union as Zubsolv for:
  • Opioid dependence

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Findings from Research

The study will involve 280 adults with opioid use disorder and aims to improve adherence to buprenorphine-naloxone treatment through two psychological interventions: contingency management (CM) and brief motivational interviewing plus substance-free activities and mindfulness (BSM).
The primary goal is to assess which intervention is more effective in promoting medication adherence, measured by attendance at physician appointments and the presence of buprenorphine in urine toxicology, with follow-up occurring 8 months after randomization.
Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder.Peter, SC., Murphy, JG., Witkiewitz, K., et al.[2023]
A survey of intravenous drug users in Helsinki revealed that 73% used buprenorphine as their primary drug, primarily for self-treating addiction or withdrawal symptoms.
The combination of buprenorphine and naloxone (Suboxone) was tried by 68% of respondents, but 80% reported negative experiences, suggesting that while it may help reduce buprenorphine abuse, its acceptance among users is low.
Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users.Alho, H., Sinclair, D., Vuori, E., et al.[2015]
The novel weekly subcutaneous buprenorphine depot formulation, CAM2038, was found to effectively block the euphoric effects of opioids and suppress withdrawal symptoms in individuals with moderate-to-severe opioid use disorder, based on a study involving 47 participants.
Both doses of CAM2038 (24 mg and 32 mg) were well-tolerated and demonstrated significant efficacy in preventing opioid effects, making it a promising alternative to daily oral formulations that carry risks of misuse and nonadherence.
Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial.Walsh, SL., Comer, SD., Lofwall, MR., et al.[2020]

References

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. [2023]
Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. [2015]
Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]
Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. [2022]
Group medication management for buprenorphine/naloxone in opioid-dependent veterans. [2014]
Buprenorphine/Naloxone (Zubsolv®): A Review in Opioid Dependence. [2021]
Socio-demographic profile and help-seeking behaviour of buprenorphine abusers in Singapore. [2020]
Factors associated with non-adherence to Buprenorphine-naloxone among opioid dependent African-Americans: A retrospective chart review. [2022]
The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Higher buprenorphine dose associated with increased treatment retention at low threshold buprenorphine clinic: A retrospective cohort study. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security