Status:
WITHDRAWN
Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement in B/N Treatment -RCT
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Cambridge Health Alliance
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving Buprenorphine/ Naloxone (B/N) treatment for opioid use disorder are a public health...
Detailed Description
The objective of this study is to conduct a randomized controlled trial (RCT) to evaluate an innovative strategy among opioid use disorder patients being discharged from detox. This study will evaluat...
Eligibility Criteria
Inclusion
- age 18 to 65 years
- opioid use disorder
- stepping down from inpatient detox services
- willing to engage in daily outpatient supervised dosing of B/N.
Exclusion
- cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA \< 25/30 relative exclusion requiring PI approval, absolute exclusion for MOCA\<21/30) (Nasreddine,et al., 2005)
- homeless without any expressed interest in attaining housing after detox discharge
- reporting active homicidal or suicidal ideation with an imminent plan
- current mania or psychosis
- expected incarceration in next 3 months (those that are incarcerated during the study will be removed from the study)
- unable or unwilling to use a mobile device
- medical contraindication to B/N
- unable to complete baseline assessments
- unstable medical illness who expect hospitalization in the next 3 months
- pregnant women (if a patient becomes pregnant while participating in this study, they will be withdrawn)
- prisoners
- court-ordered individuals
- is non-English speaking
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04822168
Start Date
December 31 2021
End Date
April 5 2022
Last Update
December 7 2021
Active Locations (1)
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1
ACTS Adult Addiction Receiving Facility (AARF)
Tampa, Florida, United States, 33610