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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
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 moreSecondary outcome measures
Cravings
Opioid use
Patient satisfaction
+2 moreTrial 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.
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Who is running the clinical trial?
Bicycle HealthLead Sponsor
Scott Weiner, MD, MPHPrincipal InvestigatorBicycle Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are experiencing strong cravings or withdrawal symptoms from a substance at the time of the study.You have not taken any strong pain medications that were not prescribed by a doctor within the last day.You have an allergy or sensitivity to buprenorphine/naloxone medication.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional Induction Arm
- Group 2: Microdosing Induction Arm
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Microdosing Induction Arm received authorization from the FDA?
"Based on the phase 4 status of Microdosing Induction Arm, our team at Power rated this treatment as a 3 for safety. This indicates that it has already been approved by regulatory bodies."
Answered by AI
Is there still availability for individuals to enroll in this medical experiment?
"Contrary to what is listed on clinicaltrials.gov, this medical trial is not presently recruiting patients - however it was initially posted in January 1st of 2023 and had its last update on November 30th 2022. There are numerous other studies that may be of interest with 411 actively enrolling participants at the moment."
Answered by AI
What are the core aims of this research project?
"Bicycle Health, the sponsor of this trial, has identified Modified-Clinical Opiate Withdrawal Scale (M-COWS) scores as their primary measure over a 10 day period. Additionally, they will be evaluating patient satisfaction on a 5 point scale, treatment retention at visit days 10 and 30 and cravings levels reported by participants themselves."
Answered by AI
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