Clinical trial NCT05450718: Low-dose Buprenorphine Initiation for Opioid Use Disorder
Official title: A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
micro-induction
microdosing
low-dose initiation
buprenorphine
micro-initiation
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.

Detailed description: After being informed about the study and potential risks, all participants will be given written informed consent. Eligible participants will be randomized in a 1:1 ratio to an 8-day low-dose buprenorphine initiation protocol or treatment as usual, and conduct study visits at baseline and weeks 2 and 4. The investigators will also provide participants with mobile phones to collect real-time data on withdrawal, anxiety, craving and substance use through electronic Ecological Momentary Assessment (EMA) technology.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Any gender, aged 18 years or greater
4. Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
5. Ability to take sublingual medication
6. Willingness to adhere to the assigned buprenorphine initiation regimen
7. Fluency in English or Spanish
8. For participants of reproductive potential: agreement to use highly effective contraception during study participation

Exclusion Criteria:

1. Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone
2. Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
3. Severe untreated mental illness, meaning psychosis or suicidality
4. Presence of an acute or chronic medical condition that would make participation medically hazardous
5. Pregnancy or lactation
6. Known allergic reactions to buprenorphine or naloxone
7. Inability to consent due to cognitive impairment

Primary outcomes:
measure: Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
timeFrame: At baseline study visit (time zero)
Secondary outcomes:
measure: Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol.
timeFrame: From baseline to day 8
measure: Number of participants who uptake buprenorphine treatment at 2 weeks
timeFrame: 2-week study visit
measure: Number of participants retained in buprenorphine treatment at 6 weeks
timeFrame: 6-week study visit
measure: Non-prescribed opioid use
timeFrame: From baseline to 6-week study visit
measure: Withdrawal severity
timeFrame: From baseline to 2-week study visit
measure: Precipitated withdrawal
timeFrame: From baseline to 2-week study visit
measure: Mild vs Mod-Severe Withdrawal symptoms
timeFrame: From baseline to 2-week study visit
Other outcomes:
measure: Changes in severity of withdrawal scores during buprenorphine initiation buprenorphine initiation
timeFrame: From baseline to 2-week study visit
measure: Changes in severity of anxiety scores during buprenorphine initiation
timeFrame: From baseline to 2-week study visit
measure: Changes in severity of cravings scores during buprenorphine initiation
timeFrame: From baseline to 2-week study visit
measure: Non-prescribed opioid use during buprenorphine initiation
timeFrame: baseline to 2-week study visit
measure: Fentanyl exposure after buprenorphine initiation
timeFrame: baseline to 2-week study visit
measure: Non-fatal opioid overdose since last study visit
timeFrame: baseline to 6-week study visit
measure: Strict Protocol Fidelity
timeFrame: baseline- day 7
measure: Proportional fidelity
timeFrame: baseline- day 7
measure: Provider time-burden
timeFrame: 8 days
measure: Proportion of doses of buprenorphine taken according to treatment as usual arm initiation protocol
timeFrame: baseline to day 2
measure: Withdrawal symptoms at 1 week
timeFrame: day 7
measure: Opioid cravings over 1st week of buprenorphine initiation
timeFrame: day 0-7
measure: Anxiety severity at 1 week
timeFrame: day 7
measure: Mild vs Mod-Severe Withdrawal symptoms
timeFrame: baseline to 2-week visit
measure: Buprenorphine treatment uptake, clinical visit
timeFrame: 2-week visit
measure: First buprenorphine-naloxone (bup-nx) dose
timeFrame: Day 0-1
measure: Buprenorphine-naloxone (bup-nx) Dose per day
timeFrame: Baseline - day 8
measure: Buprenorphine-naloxone (bup-nx) Dose variability
timeFrame: Baseline - day 8
measure: Continued use of full-agonist opioid during initiation protocol (yes/no)
timeFrame: Baseline - day 8
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin T Hayes, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References: