NCT05518461

Smartphone Intervention for Overdose and COVID-19

Completed NA Results posted Last updated 5 December 2024

What this trial tests

NA trial testing iThrive WI Intervention in Substance Use Disorders in 60 participants. Completed in 15 December 2023.

Timeline

19 December 2022

Primary endpoint
15 December 2023

15 December 2023

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	60
Start date	19 December 2022
Primary completion	15 December 2023
Estimated completion	15 December 2023
Sites	1 location across United States

Drugs / interventions tested

• iThrive WI Intervention

Conditions studied

• Substance Use Disorders — all drugs for Substance Use Disorders →
• Overdose — all drugs for Overdose →
• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Substance Use Disorders or Overdose. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention Primary · up to 12 weeks

Study feasibility will be in part based on intervention content completion rates. The study will be considered feasible if participants complete any intervention content on at least 50% (i.e., 6) of the 12 weeks. We will report the number of participants who completed at least 6 of the 12 weeks.

Group	Value	95% CI
iThrive WI Intervention	40

Number of Days in the Past Month Endorsing Overdose Risk Behaviors Secondary · baseline, 3 months, 6 months

Preliminary effectiveness will in part be measured by examining the number of days in the previous month endorsing overdose risk behaviors at months 3 and 6 (relative to baseline/study enrollment). Overdose risk behavior frequency will be assessed by participant self-report.

baseline

Group	Value	95% CI
Non-Injection Opioid Use	2	0 – 10
Using Opioids or Stimulants While Alone	5	0 – 15
Injection Drug Use and/or Speedballing	14	9 – 23
Opioid and Alcohol Use	0	0 – 1
Opioid and Benzodiazepine Use	0	0 – 0

3 months

Group	Value	95% CI
Non-Injection Opioid Use	0	0 – 3
Using Opioids or Stimulants While Alone	3	0 – 10
Injection Drug Use and/or Speedballing	9	4 – 16
Opioid and Alcohol Use	0	0 – 0
Opioid and Benzodiazepine Use	0	0 – 0

6 months

Group	Value	95% CI
Non-Injection Opioid Use	0	0 – 7
Using Opioids or Stimulants While Alone	1	0 – 7
Injection Drug Use and/or Speedballing	5	1 – 16
Opioid and Alcohol Use	0	0 – 0
Opioid and Benzodiazepine Use	0	0 – 0

Change in COVID-19 Vaccination Rates From Baseline Secondary · baseline, 3 months, 6 months

Preliminary effectiveness will in part be assessed by measuring the proportion of participants vaccinated against COVID-19 at baseline and at months 3 and 6.

baseline

Group	Value	95% CI
iThrive WI Intervention	30

3 months

Group	Value	95% CI
iThrive WI Intervention	16

6 months

Group	Value	95% CI
iThrive WI Intervention	17

Sponsor's own description

This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Mobile Health Application to Support Reductions in Overdose Risk Behaviors: A Pilot Study.
   Conway CJ, Uhm S, Becker M, Mijal K, et al · · 2026 · PMID 40737120 · DOI 10.1177/29767342251355154