Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT07649278

Conditions

Substance Related Disorder

Drug Overdose

eHealth

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Connections mHealth Application

Study Details

Brief summary:

This study will examine the feasibility, appropriateness, and acceptability of a bundle of smartphone-based tools for lowering overdose risk. 40 participants will be enrolled and can expect to be on study for up to 9 months.

Conditions

Substance Related Disorder

Drug Overdose

eHealth

Study ID

NCT07649278

Start date

Jul 1, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (Pilot Participant):

  • Be at least 18 years old
  • Be able to read and write in English
  • Report drug use in the past 30 days, defined as

  • Any use of illicit stimulants, opioids, OR
  • Use of prescription opioids by a route other than "by mouth/swallowed"
  • Additionally report recent drug use of at least twice in the past 7 days
  • Have NOT used any of the following harm reduction services in the past 6 months:

  • In-person community-based prevention services for people who use drugs
  • Overdose crisis hotlines
  • Online mail-order prevention supply delivery
  • Apps for supporting addiction treatment or recovery

Inclusion Criteria (Peer Mentor Participant):

  • Be at least 18 years old
  • Be able to read and write in English
  • Have served as a member of the existing Community Leadership Team.

Exclusion Criteria:

  • Are under the age of 18
  • Have impaired decision making capacity at the time of screening
  • Do not have the ability to participate in screening and enrollment activities in any one of the following ways:

  • Traveling to their nearest participating Vivent Health health center
  • Coordinating a visit with the Vivent Health harm reduction mobile unit
  • Accessing and completing the online screening survey on a personal wifi/internet enabled device

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Pilot Participants

People who use opioid and/or stimulant drugs and are disconnected from harm reduction services.

Interventions

Connections mHealth Application

Mobile health app, bundled with other harm reduction internet and phone resources

Primary outcome measure

  • Acceptability of Intervention Measure (AIM) [ Time Frame: up to 6 months ]
  • Intervention Appropriateness Measure (IAM) [ Time Frame: up to 6 months ]
  • Feasibility of Intervention Measure (FIM) [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Locations

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 14, 2026

Last verified

Jun, 2026

Keywords

  • Substance Use Disorder
  • Opioid Use Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-14.