Opioid Use Clinical Trial
Official title:
Novel Induction to Buprenorphine/Naloxone: A Quasi-Experimental Study With Comparison Group
Verified date | February 2023 |
Source | Bicycle Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 170 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Bicycle Health | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Bicycle Health |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who complete induction with no/mild withdrawal | Completion of induction with no/mild withdrawal | 10 days | |
Primary | 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 | |
Primary | 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 | |
Primary | Adverse outcomes | Any untoward medial occurrence | 10 days | |
Secondary | Treatment retention | Patient attendance at visit with a participating provider on day 10 and day 30 | 30 days | |
Secondary | Opioid use | Self-reported return to opioid use after buprenorphine/naloxone induction | 30 days | |
Secondary | Toxicology screens | Opioid appearance in drug screens | 30 days | |
Secondary | Cravings | Patient self-reported opioid-related cravings | 30 days | |
Secondary | Patient satisfaction | On a scale of 1 (highly unsatisfactory) to 5 (highly satisfactory), participants will be asked to rate their satisfaction with the buprenorphine induction process. | 30 days |
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