CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

MySafeRx Inspire FlexWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug429 CD24Fc Wiki 1.00
drug1536 MySafeRx Inspire Plus Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement and Retention in Buprenorphine Treatment (MySafeRx) - A Pilot Study

Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving buprenorphine 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 Buprenorphine/ Naloxone (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.

NCT04449744 Opioid-use Disorder Other: MySafeRx Inspire Plus Other: MySafeRx Inspire Flex

Primary Outcomes

Description: To examine the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing. MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals). MySafeRx Participant Satisfaction Survey to assess for acceptability of electronic dispenser.

Measure: Acceptability of Medication Dispenser

Time: 12 weeks

Secondary Outcomes

Description: To examine the differences in illicit opioid use throughout the 24 weeks of the study as measured by urine toxicology testing every 4 weeks between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need). Positive results for fentanyl, opiates, methadone and oxycodone will be measured at 6 time points every 4 weeks.

Measure: Biochemically-Confirmed Illicit Opioid Use

Time: 24 weeks

Description: To examine medication adherence to Buprenorphine (B/N) by assessing the differences between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) in the total number of observed B/N doses taken in the first 28 days, between weeks 3-6. To be measured by examining adherence data from the study site EHR system and MySafeRx application.

Measure: Outpatient Buprenorphine Medication Adherence

Time: 16 weeks

Description: To examine the differential impact of two tele-health interventions of MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing through 24 weeks.To be measured by examining adherence data from the study site EHR system and MySafeRx application.

Measure: Outpatient Buprenorphine Treatment Engagement/ Retention

Time: 24 weeks

Other Outcomes

Description: To examine the difference in engagement defined as the proportion of participants assigned to Group A or Group B, who have an observed B/N dosing on at least 10 out of the first 14 days.

Measure: Proportion of days engaged in observed daily dosing of Buprenorphine during first 2 weeks.

Time: Between the day after detox discharge to two-week time point

Description: To examine the differences of COVID-19 infection between MySafeRx Group A (coaching + medication dispenser) MySafeRx Group B in comparison with the local treatment sites overall program incidence rate during the time period. Measured with COVID-19 self-report survey.

Measure: COVID-19 Infections

Time: 24 weeks

Description: To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on the number of self-reported, county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study.

Measure: Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)

Time: 24 weeks

Description: To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on all opioid-related deaths (in which opioids were present at time of death), as collected through county coroner reports and community network reports, throughout the 24 weeks of the study.

Measure: Opioid-Related Death Rates

Time: 24 weeks

No related HPO nodes (Using clinical trials)