Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement in B/N Treatment -RCT
Withdrawn before enrolling · Not applicable
Conditions studied: Opioid-use Disorder
In brief
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 priority. This study will both investigate the effects of starting remote motivational enhancement during inpatient detoxification on rates of engagement in B/N treatment and evaluate the impact of MySafeRx, a mobile device application which integrates remote motivational coaching with daily observed dosing from secure electronic pill dispensers at home via videoconference, on treatment retention and overdose prevention. Broad dissemination of this new intervention could help communities across the nation expand and advance their capacity to increase B/N treatment engagement and retention, enhance medication adherence, and prevent overdose.
Key facts
- Study ID
- NCT04822168
- Run by
- University of South Florida
- People needed
- 0
- Starts
- 2021-12-31
- Expected to finish
- 2022-04-05
- Last updated by the study team
- 2021-12-07
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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- pregnant women (if a patient becomes pregnant while participating in this study, they will be withdrawn)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
Where it is running
- ACTS Adult Addiction Receiving Facility (AARF) — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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