250 Participants Needed

Buprenorphine for Opioid Use Disorder

(Optimal Bup Trial)

AP
RW
FB
Overseen ByFrancesca Beaudoin
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Rhode Island Hospital
Must be taking: Buprenorphine
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

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those whose medications might interact seriously with buprenorphine. It's best to discuss your current medications with the trial team to see if they might be a concern.

Is buprenorphine safe for humans?

Buprenorphine is generally considered safe for humans, with studies showing it has fewer side effects and less risk of respiratory issues compared to other opioids. It is used to treat opioid dependence and has a high safety profile, even when combined with naloxone to prevent misuse. While some symptoms like neurological effects can occur, serious complications are rare, and it is associated with a lower risk of overdose deaths.12345

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

Buprenorphine is unique because it can be administered as a weekly depot injection, which helps prevent misuse and ensures consistent medication levels, unlike daily oral forms that can be misused or skipped. Additionally, it can be initiated without stopping other opioid pain medications, making it easier for patients with co-occurring pain to start treatment.678910

What data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder?

Research shows that Buprenorphine is an effective treatment for opioid use disorder, helping people recover by reducing misuse and improving treatment outcomes. Sustained-release formulations of Buprenorphine can address issues like misuse and nonadherence, making it a reliable option for long-term treatment.78101112

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe opioid use disorder, specifically those who have used fentanyl. Participants must speak English and be starting or already receiving buprenorphine treatment. They should have a history of fentanyl use confirmed by tests or self-report.

Inclusion Criteria

I speak English.
My doctor says I have a serious opioid addiction.
I am starting or already on buprenorphine for opioid addiction.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 16 mg or 24 mg daily maintenance dose of buprenorphine

6 months
Monthly visits for urine drug screens and self-reports

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Data collection from statewide health systems

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine
Trial Overview The study compares two doses of buprenorphine: a high dose (24 mg) versus the standard dose (16 mg) in patients using fentanyl. It looks at how well each dose keeps patients in treatment, reduces non-prescribed opioid use, lessens cravings, and prevents overdoses.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: High Maintenance Daily Dose (24mg)Experimental Treatment1 Intervention
Group II: Standard Maintenance Daily Dose (16mg)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

Brown University

Collaborator

Trials
480
Recruited
724,000+

Published Research Related to This Trial

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]
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]
Buprenorphine is a safe and effective treatment for opioid use disorder (OUD) in emergency departments, acting as a partial mu-opioid receptor agonist with a long half-life and a ceiling effect that reduces the risk of overdose and withdrawal symptoms.
Implementing a buprenorphine program in the ED requires a comprehensive approach that includes medication-assisted treatment, counseling, and addressing the stigma associated with opioid replacement therapies to improve patient outcomes.
Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting.Cisewski, DH., Santos, C., Koyfman, A., et al.[2019]

Citations

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]
Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]
Buprenorphine utilization among all Washington State residents' based upon prescription monitoring program data - Characteristics associated with two measures of retention and patterns of care over time. [2021]
Approach to buprenorphine use for opioid withdrawal treatment in the emergency setting. [2019]
Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. [2022]
Buprenorphine infrequently found in fatal overdose in New York City. [2018]
Buprenorphine exposures in adolescents and adults: a 10-year experience of a French Poison Control Center. [2021]
A Question About the Safety of Buprenorphine/Naloxone and Benzodiazepine Drugs. [2015]
Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
The New Kid on the Block--Incorporating Buprenorphine into a Medical Toxicology Practice. [2018]
Use of intravenous buprenorphine microdosing to initiate medication for opioid use disorder in a patient with co-occurring pain: case report. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Association of Project ECHO Training With Buprenorphine Prescribing by Primary Care Clinicians in Minnesota for Treating Opioid Use Disorder. [2023]
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