Study Stopped
Low enrollment numbers
Novel Induction to Buprenorphine/Naloxone
1 other identifier
interventional
33
1 country
1
Brief Summary
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction. Patients take small doses of buprenorphine/naloxone that increase slowly over a week. Although microdosing induction has been supported anecdotally, its effectiveness is not known. The proposed study will compare the effectiveness and safety of two induction strategies for transitioning patients from opioids to buprenorphine/naloxone. All inductions will occur in an outpatient telehealth opioid use disorder (OUD) treatment setting. The study will compare patients who receive traditional induction versus microdosing induction. Primary outcomes include effectiveness and safety. Secondary outcomes include treatment retention, self-reported use of opioids during induction, return to opioid use, opioid appearance in drug screens, craving/withdrawal symptoms, and patient satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedAugust 20, 2024
August 1, 2024
10 months
November 21, 2022
August 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of participants who complete induction with no/mild withdrawal
Completion of induction with no/mild withdrawal
10 days
Modified-Clinical Opiate Withdrawal Scale (M-COWS) scores
Average/median and Maximum M-COWS scores for each participant. Scores range from 0-48, with higher scores indicating more withdrawal symptoms.
10 days
Subjective Opiate Withdrawal Scale (SOWS) scores
Average/median SOWS scores for each participant. Score range from 0-64, with higher scores indicating more withdrawal symptoms.
10 days
Adverse outcomes
Any untoward medial occurrence
10 days
Secondary Outcomes (5)
Treatment retention
30 days
Opioid use
30 days
Toxicology screens
30 days
Cravings
30 days
Patient satisfaction
30 days
Study Arms (2)
Traditional Induction Arm
ACTIVE COMPARATORIn 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.
Microdosing Induction Arm
ACTIVE COMPARATORIn 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.
Interventions
Buprenorphine/naloxone will be used to begin each patient's treatment for opioid use disorder.
Eligibility Criteria
You may qualify if:
- Enrollment with Bicycle Health services
- Aged 18 years old or older
- Diagnosis of opioid use disorder confirmed by DSM-5 criteria
- In no/mild withdrawal at the time of intake
- Need to undergo induction to buprenorphine from a full opioid agonist
- Use of full opioid agonists not directly from a pharmacy within the last 24 hours
- Pharmacy stock check of 2 mg film/tablet done before visit
- Willingness and ability to follow study protocols, and the ability to provide informed consent
You may not qualify if:
- Known allergy or sensitivity to buprenorphine/naloxone
- Any circumstance that precludes the need for induction
- In moderate to severe withdrawal at the time of intake
- Severe or complex medical/psychiatric comorbidity that requires a customized induction schedule or surveillance
- Any element that would exclude an individual from Bicycle Health services in general (e.g., homelessness, severe untreated mental illness)
- Patients requesting specific induction technique
- Patients who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bicycle Healthlead
Study Sites (1)
Bicycle Health
Boston, Massachusetts, 02111, United States
Related Publications (1)
Hammig R, Kemter A, Strasser J, von Bardeleben U, Gugger B, Walter M, Dursteler KM, Vogel M. Use of microdoses for induction of buprenorphine treatment with overlapping full opioid agonist use: the Bernese method. Subst Abuse Rehabil. 2016 Jul 20;7:99-105. doi: 10.2147/SAR.S109919. eCollection 2016.
PMID: 27499655BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Weiner, MD, MPH
Bicycle Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 9, 2022
Study Start
February 6, 2023
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
August 20, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share