← Back to Search

Opioid Agonist

Buprenorphine/Naloxone Induction for Opioid Addiction

Phase 4
Waitlist Available
Led By Scott Weiner, MD, MPH
Research Sponsored by Bicycle Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial will compare two methods of transitioning patients off opioids to buprenorphine/naloxone with the goal of finding a safer and more effective way.

Who is the study for?
This trial is for adults over 18 with opioid use disorder who need to switch to buprenorphine/naloxone and can follow the study plan. They should be in no or mild withdrawal, not have used opioids from non-pharmacy sources in the last day, and able to consent. It's not for those in severe withdrawal, with complex health issues, specific induction requests, pregnant/lactating women, or allergies to the medication.Check my eligibility
What is being tested?
The study tests a new way of starting buprenorphine/naloxone called microdosing induction against traditional methods. Patients will either get small increasing doses over a week without severe withdrawal (microdosing) or go through standard induction. The main goals are to see which method is safer and more effective using telehealth services.See study design
What are the potential side effects?
Buprenorphine/naloxone may cause side effects like headaches, nausea, vomiting, drug withdrawal syndrome when transitioning from other opioids, insomnia and constipation. Side effects vary by individual and dosing strategy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse outcomes
Modified-Clinical Opiate Withdrawal Scale (M-COWS) scores
Number of participants who complete induction with no/mild withdrawal
+1 more
Secondary outcome measures
Cravings
Opioid use
Patient satisfaction
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Traditional Induction ArmActive Control1 Intervention
In this arm, study participants will wait until they have significant opioid withdrawal (SOWS score >=17) prior to starting buprenorphine. Participants will then started with 2 mg sublingual and escalate to a maximum of 12 mg on the first day depending on withdrawal symptoms. On day 2, the participant will take same dose as the total dose taken on day 1, and continue that dose daily until reevaluation.
Group II: Microdosing Induction ArmActive Control1 Intervention
In this arm, study participants will not wait until they have significant opioid withdrawal. They will take 0.5 mg buprenorphine on day 1, 2 mg on day 2, 4 mg on day 3, 6 mg on day 4, 8 mg on day 5 and 12 mg starting on day 6.

Find a Location

Who is running the clinical trial?

Bicycle HealthLead Sponsor
Scott Weiner, MD, MPHPrincipal InvestigatorBicycle Health

Media Library

Buprenorphine/Naloxone (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05644587 — Phase 4
Opioid Use Disorder Research Study Groups: Traditional Induction Arm, Microdosing Induction Arm
Opioid Use Disorder Clinical Trial 2023: Buprenorphine/Naloxone Highlights & Side Effects. Trial Name: NCT05644587 — Phase 4
Buprenorphine/Naloxone (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05644587 — Phase 4
~76 spots leftby May 2025
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