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Women's Opioid Treatment Follow-up Study

Not Applicable
Recruiting
Conditions
Opioid Use Disorder
Registration Number
NCT05776966
Lead Sponsor
Mclean Hospital
Brief Summary

The goal of this study is to examine the feasibility of a gender-specific digital intervention for women with opioid use disorder. In this study, women with opioid use disorder will be randomized to receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only. Feasibility, satisfaction, and engagement with the intervention are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-up visits.

Detailed Description

This study has two aims: (1) to demonstrate the feasibility of delivering a gender-specific digital intervention (GSDI) to women with opioid use disorder; (2) to collect preliminary estimates on the effect of the GSDI on engagement in medication treatment for opioid use disorder (MOUD). The investigators will conduct a pilot randomized controlled trial to achieve these aims. Women (N=40) who have recently initiated MOUD (within 30 days) will be enrolled and randomized to receive either the GSDI+TAU (gender-specific digital intervention + treatment as usual) or TAU-only. Feasibility, satisfaction, and engagement with the GSDI are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-ups. MOUD engagement will be assessed at two time-points: (1) 6-weeks and (2) 12-weeks post-enrollment to collect preliminary estimates on the effect of the GSDI on MOUD engagement.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
40
Inclusion Criteria
  • age 18 years of age or older
  • current opioid use disorder diagnosis
  • have a smartphone
  • initiated medication treatment for opioid use disorder in the past 30 days,
  • able to provide informed consent
Exclusion Criteria
  • an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures
  • admitted to their current treatment episode on an involuntary status

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Engagement metricsWeek 1 - Week 12

Engagement data will be retrieved from MetricWire including number of logins, number of completed check-ins and skills practices, and time spent on each of these activities. Time spent on the web-based portion of the GSDI will be calculated from REDCap.

Client Satisfaction QuestionnaireImmediately after the web-based portion of the intervention, Week 12

The Client Satisfaction Questionnaire (CSQ) assesses participant satisfaction of the digital intervention. The original CSQ has 8 items and we have added an additional 8 items to gather satisfaction with specific aspects of the digital intervention.

System Usability Scale12 weeks

The System Usability Scale (SUS) is a 10-item questionnaire with five response options for respondents from Strongly agree to Strongly disagree. The SUS is used to measure usability of products and services, including hardware, software, mobile devices, websites, and applications.

Qualitative Exit InterviewWeek 12

Qualitative user experience exit interviews will be coded and analyzed using thematic analysis methodology to identify common themes.

Secondary Outcome Measures
NameTimeMethod
Timeline FollowbackWeek 2, Week 6, Week 12

The Timeline Followback calendar method will be used to collect self-report data on medication for opioid use disorder adherence.

Trial Locations

Locations (1)

McLean Hospital

🇺🇸

Belmont, Massachusetts, United States

McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Dawn Sugarman, PhD
Contact
617-855-3650
dsugarman@mclean.harvard.edu

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