Opioid Use Disorder
Conditions
Brief summary
This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).
Detailed description
The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.
Interventions
DRUGBuprenorphine SL
Up to 24 mg per day
OTHERTelehealth
Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
OTHERIn-person treatment as usual
in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.
Sponsors
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, active-control, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* meet DSM-5 criteria for OUD * Voluntarily seeking buprenorphine treatment for OUD * Able to provide informed consent and comply with study procedures
Exclusion criteria
* Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification * Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder * Concurrent methadone, buprenorphine, or vivitrol maintenance treatment * Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine) * Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients * Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation * Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide * Legally mandated to substance use disorder treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to drop out | 12 weeks | Comparing time to drop out between the treatment arms |
Contacts
PRINCIPAL_INVESTIGATORChristina Brezing, MD
New York State Psychiatric Institute
Outcome results
None listed