Brief Summary
Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and experience opioid withdrawal before starting BUP. Investigators propose to test BUP microdose inductions vs. TAU in a randomized controlled trial.
Brief Title
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
Detailed Description
Investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open-label, randomized controlled trial (RCT). Investigators will randomize 270 hospitalized patients with (a) chronic pain and (b) opioid misuse or opioid use disorder (OUD) to a 5-day BUP microdose induction protocol (without stopping full agonists) or 2-day standard induction (with stopping full agonists), and then link participants to outpatient BUP treatment when they are released from the hospital. Study assessment visits will occur at baseline, 1 week, and 1, 3, and 6 months. Assessments will include interviews and urine drug tests to determine whether participants start BUP, continue BUP, have improvements in pain and decrease illicit opioid use. During induction and 3-months of follow-up, investigators will also collect data on mobile devices to assess opioid withdrawal, opioid craving, pain, and anxiety. These data will allow investigators to assess whether BUP microdosing targets of engagement-opioid- and pain-related symptoms-mediate OUD outcomes. Exploratory analyses will also examine pain as a trigger for opioid relapse.
Aim 1: To test the effectiveness of BUP microdose induction (vs. TAU) on OUD outcomes.
H1: The microdose arm (vs. TAU) will have better BUP treatment uptake and retention, and less illicit opioid use.
H2: Improvements in H1 will be mediated by opioid- and pain-related symptoms.
Aim 2: To test the effectiveness of microdosing (vs. TAU) on pain outcomes. H3: The microdose arm (vs. TAU) will have less pain intensity and interference, and improved quality of life.
H4: Improvements in H3 will be mediated by OUD outcomes.
Aim 3: To inform future implementation and dissemination efforts, investigators will:
3a) Examine factors influencing reach, adoption, implementation, and maintenance of BUP microdosing. Investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains; 3b) Calculate the cost and examine cost-effectiveness of BUP microdosing. H5: Compared with TAU, BUP microdosing will be cost-effective from a societal and a health sector perspective.
Aim 1: To test the effectiveness of BUP microdose induction (vs. TAU) on OUD outcomes.
H1: The microdose arm (vs. TAU) will have better BUP treatment uptake and retention, and less illicit opioid use.
H2: Improvements in H1 will be mediated by opioid- and pain-related symptoms.
Aim 2: To test the effectiveness of microdosing (vs. TAU) on pain outcomes. H3: The microdose arm (vs. TAU) will have less pain intensity and interference, and improved quality of life.
H4: Improvements in H3 will be mediated by OUD outcomes.
Aim 3: To inform future implementation and dissemination efforts, investigators will:
3a) Examine factors influencing reach, adoption, implementation, and maintenance of BUP microdosing. Investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains; 3b) Calculate the cost and examine cost-effectiveness of BUP microdosing. H5: Compared with TAU, BUP microdosing will be cost-effective from a societal and a health sector perspective.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Substance Use Disorders
Opioid-use Disorder
Chronic Pain
Eligibility Criteria
Inclusion Criteria:
* Age \> 18 years
* Opioid misuse or OUD
* Chronic pain
* Currently taking opioids
* Fluency in English or Spanish
* Planned hospitalization for ≥ 48 hours
Exclusion Criteria:
* Current OUD treatment (BUP, methadone, naltrexone)
* Severe alcohol or benzodiazepine use disorder
* Hypersensitivity to BUP or naloxone
* Pain due to malignancy
* Severe untreated mental illness (suicidality, psychosis)
* Pregnancy
* Unable to consent due to pain or cognitive impairment
* Age \> 18 years
* Opioid misuse or OUD
* Chronic pain
* Currently taking opioids
* Fluency in English or Spanish
* Planned hospitalization for ≥ 48 hours
Exclusion Criteria:
* Current OUD treatment (BUP, methadone, naltrexone)
* Severe alcohol or benzodiazepine use disorder
* Hypersensitivity to BUP or naloxone
* Pain due to malignancy
* Severe untreated mental illness (suicidality, psychosis)
* Pregnancy
* Unable to consent due to pain or cognitive impairment
Inclusion Criteria
Inclusion Criteria:
* Age \> 18 years
* Opioid misuse or OUD
* Chronic pain
* Currently taking opioids
* Fluency in English or Spanish
* Planned hospitalization for ≥ 48 hours
* Age \> 18 years
* Opioid misuse or OUD
* Chronic pain
* Currently taking opioids
* Fluency in English or Spanish
* Planned hospitalization for ≥ 48 hours
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05118204
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-13311
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
Primary Outcomes
Outcome Description
The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.
Outcome Measure
BUP treatment uptake
Outcome Time Frame
7 days
Secondary Ids
Secondary Id
1RM1DA055437-01
Secondary Outcomes
Outcome Description
The mean number of days of illicit opioid use, defined as self-reported use of heroin, fentanyl, or non-prescribed opioid analgesics in the prior 30 days based on the Addiction Severity Index, will be reported for each arm.
Outcome Time Frame
1, 3, and 6 months
Outcome Measure
Illicit opioid use
Outcome Description
The percentage of participants who are retained in BUP treatment, defined as having a BUP prescription written 180-210 days (6-month retention) after enrollment, will be reported for each arm.
Outcome Time Frame
1, 3, and 6 months
Outcome Measure
BUP retention in care
Outcome Description
Mean pain intensity score, measured using the Brief Pain Inventory (BPI), will be reported for each study arm.
Outcome Time Frame
3 months
Outcome Measure
Pain Intensity
Outcome Description
Mean pain interference score, measured using the pain interference scale from the BPI, which is a 7-item instrument measuring the impact of pain on daily activities and physical functioning, will be reported for each study arm.
Outcome Time Frame
3 months
Outcome Measure
Pain interference
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
Aaron Fox
Investigator Email
adfox@montefiore.org
Investigator Phone
718-920-7173