Low-dose Buprenorphine Initiation of Opioid Use Disorder
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-dose initiation Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone according to an at-home, 8-day protocol (below). Participants in the low-dose BUP initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone. Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours |
Drug: buprenorphine-naloxone
Low-dose initiation of buprenorphine-naloxone protocol
Other Names:
|
| Active Comparator: Treatment as usual Participants randomized to treatment as usual will start buprenorphine-naloxone following standard clinical guidelines for two-day, at-home initiation. |
Drug: buprenorphine-naloxone
Standard clinical guidelines for a two-day buprenorphine-naloxone initiation
|
Outcome Measures
Primary Outcome Measures
- Number of participants who uptake buprenorphine treatment at 2 weeks [2-week study visit]
Uptake is defined as having a positive urine drug test (UDT) for buprenorphine at the 2-week study visit (dichotomous, yes/no).
Secondary Outcome Measures
- Number of participants retained in buprenorphine treatment at 4 weeks [4-week study visit]
4-week retention is defined as having an active buprenorphine prescription and buprenorphine-positive UDT at the 4-week visit
- Number of days of illicit opioid use [From baseline to 4-week study visit]
Illicit opioid use will be examined as the number of days of illicit opioid use (defined as self-reported heroin, fentanyl, or non-prescribed opioid analgesics) over the study period, collected using a modified Addiction Severity Index (continuous).
- Proportion of doses of buprenorphine taken according to treatment as usual arm initiation protocol [From baseline to day 2]
Measured using once daily participant self-report through Ecological Momentary Assessment technology and defined as the proportion of pre-packaged doses taken each day during the initiation protocol.
- Proportion of doses of buprenorphine taken according to low-dose protocol initiation protocols [From baseline to day 8]
Measured using once daily participant self-report through Ecological Momentary Assessment technology and defined as the proportion of pre-packaged doses taken each day during the initiation protocol.
- The number and severity of withdrawal events recorded daily through self-report and Subjective Opioid Withdrawal Scale Ecological Momentary Assessment technology [From baseline to 4-week study visit]
Investigators will measure the frequency and severity of events, following the trend over time and compare area under the curve at 2 weeks (after initiation period) and 4 weeks (after period of treatment maintenance). Subjective Opioid Withdrawal Score is a 16-items scaled on symptom severity (scale from 0=Not at all to 4=extremely). Withdrawal events will be classified as mild, moderate, or severe. Investigators will compare the percentage of severe and mild-moderate buprenorphine-related withdrawal events between low-dose buprenorphine initiation and treatment as usual.
Other Outcome Measures
- Changes in severity of withdrawal scores during buprenorphine initiation buprenorphine initiation [From baseline to 4-week study visit]
Using multilevel mixed-linear effects models to examine effects within individuals (level 1), and between study arms (level 2) of Subjective Opioid Withdrawal Score, 16-items scaled on symptom severity (scale from 0=Not at all to 4=extremely) scored as mild, mod, and severe withdrawal. Data collected using Ecological Momentary Assessment technology.
- Changes in severity of anxiety scores during buprenorphine initiation [From baseline to 4-week study visit]
Using multilevel mixed-linear effects models to examine effects within individuals (level 1), and between study arms (level 2) of Generalized Anxiety Disorder-7 scale, 7-items scaled on symptom frequency (scale from 0=Not at all to 3=Nearly every day), scored from minimal to severe anxiety. Data collected using Ecological Momentary Assessment technology.
- Changes in severity of cravings scores during buprenorphine initiation [From baseline to 4-week study visit]
Using multilevel mixed-linear effects models to examine effects within individuals (level 1), and between study arms (level 2) of the Opioid Craving Scale a 3-item scale, each item 0-100 on a Visual Analog Scale from 0=None at all to 100=Extreme cravings, total score calculated by averaging the scores on the 3 items. Data collected using Ecological Momentary Assessment technology.scores on the 3 items) collected using EMA technology.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age ≥ 18 years
-
opioid use disorder by DSM-V criteria
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currently using illicit opioids
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willingness to participate in low-dose BUP initiation or TAU protocols
-
fluency in English or Spanish
Exclusion Criteria:
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receiving opioid agonist treatment in the past 30 days
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inability to provide informed consent
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unstable mental illness (e.g., suicidality, psychosis, etc.)
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moderate or severe alcohol use disorder or benzodiazepine use disorder by DSM-V criteria
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hypersensitivity to buprenorphine or naloxone.
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pregnancy (confirmed via urine testing)
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ineligible for private or public insurances
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Benjamin T Hayes, MD, MS, MPH, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-14185