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.
Brief Title
Low-dose Buprenorphine Initiation for Opioid Use Disorder
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
4156700850
Central Contact Email
bhayes@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Opioid Use Disorder
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
opioid use disorder
micro-induction
microdosing
low-dose initiation
buprenorphine
micro-initiation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05450718
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2022-14185
Overall Status
Recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
Primary Outcomes
Outcome Description
This pilot study is designed to establish the feasibility of a future, full-powered clinical trial. The primary question this study seeks to answer is whether primary care patients with opioid use disorder are willing to enroll in a clinical trial of low-dose inductions. The study will aim to enroll 25% of subjects who are assessed. "Assessed" is defined as having been referred to the study staff. Enrollment is defined as having been randomized to a treatment arm.
Outcome Measure
Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
Outcome Time Frame
At baseline study visit (time zero)
Secondary Outcomes
Outcome Description
This pilot study will seek to answer whether participants of a clinical trial adhere to a low-dose buprenorphine-naloxone (bup-nx) initiation protocol. The study aims to achieve 80% of study participants meeting adequate fidelity to the low-dose study protocol. Adequate fidelity is defined as meeting all of the following:
1. First dose is a low dose (defined as less than 1-.25mg bup-nx) (yes/no),
2. Daily bup-nx dose equivalent to assigned daily dose: For the first 7 days the reported total daily bup-nx dose is within the prespecified assigned daily dose limit,
3. Variability: Each day's daily dose is increased from the prior daily dose (within daily limits) (yes/no).
Measured using once daily participant self-report through mobile data collection technology.
1. First dose is a low dose (defined as less than 1-.25mg bup-nx) (yes/no),
2. Daily bup-nx dose equivalent to assigned daily dose: For the first 7 days the reported total daily bup-nx dose is within the prespecified assigned daily dose limit,
3. Variability: Each day's daily dose is increased from the prior daily dose (within daily limits) (yes/no).
Measured using once daily participant self-report through mobile data collection technology.
Outcome Time Frame
From baseline to day 8
Outcome Measure
Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol.
Outcome Description
Uptake is defined as having a positive urine drug test (UDT) for buprenorphine at the 2-week study visit (dichotomous, yes/no).
Outcome Time Frame
2-week study visit
Outcome Measure
Number of participants who uptake buprenorphine treatment at 2 weeks
Outcome Description
6-week retention is defined as having an active buprenorphine prescription and buprenorphine-positive UDT at the 6-week visit
Outcome Time Frame
6-week study visit
Outcome Measure
Number of participants retained in buprenorphine treatment at 6 weeks
Outcome Description
The mean number of days of non-prescribed opioid use, defined as self-reported use of heroin, fentanyl, or non-prescribed opioid analgesics in the prior 14 days using an adapted version of the Addiction Severity Index. Will be reported for each arm at the 6-week visit (continuous).
Outcome Time Frame
From baseline to 6-week study visit
Outcome Measure
Non-prescribed opioid use
Outcome Description
Measured using the Subjective Opioid Withdrawal Score, a 16-item scale based on symptom severity (from 0=Not at all, to 4=extremely). Multilevel mixed-linear effects models will be used to assess between arms.
Outcome Time Frame
From baseline to 2-week study visit
Outcome Measure
Withdrawal severity
Outcome Description
The percentage of participants who experience precipitated withdrawal during the first 2 weeks of initiation. Defined as withdrawal symptoms that get markedly worse within 90 minutes of taking buprenorphine-naloxone dose. Markedly worse will be defined as a change in 10 points on Subjective Opioid Withdrawal Score (SOWS) severity, or as determined by a study clinician. SOWS is a 16-item scale based on symptom severity (from 0=Not at all, to 4=extremely, yielding a possible overall range from 0-64). Precipitated withdrawal is expected only during periods of increasing buprenorphine-naloxone dose titrations: for the low-dose protocol precipitated withdrawal could occur from dose 1 - 13; for the treatment as usual protocol precipitated withdrawal could occur from dose 1 - 5. SOWS will be collected 5 times/day using daily mobile data collection entries.
Outcome Time Frame
From baseline to 2-week study visit
Outcome Measure
Precipitated withdrawal
Outcome Description
The proportion of severe vs mild-moderate buprenorphine-related withdrawal events between study arms will be assessed using the using the Subjective Opioid Withdrawal Score, a 16-item scale based on symptom severity (from 0=Not at all, to 4=extremely). The 16 items are summed with a score of 1-10 representing mild withdrawal, 11-20 as moderate withdrawal, and \>/= 21 as severe withdrawal.
Outcome Time Frame
From baseline to 2-week study visit
Outcome Measure
Mild vs Mod-Severe Withdrawal symptoms
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Hayes
Investigator Email
bhayes@montefiore.org
Investigator Phone
415-670-0850