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Completed

NCT Number: NCT05776966

Women's Opioid Treatment Follow-up Study

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478-1064, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gender-specific digital intervention (GSDI)

Behavioral

The GSDI is a digital intervention that incorporates factors that are more prevalent in women with opioid use disorder that may affect their treatment outcomes. The content for the intervention was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes.

Treatment as Usual

Other

Participants will receive treatment as usual for opioid use disorder which is a mix of medication treatment and individual and group therapy services across various levels of care.

Primary outcomes

  1. Client Satisfaction Questionnaire

    Time frame: Immediately 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.

  2. System Usability Scale

    Time frame: 12 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.

  3. Engagement metrics

    Time frame: Week 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.

  4. Qualitative Exit Interview

    Time frame: Week 12

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

Secondary outcomes

  1. Timeline Followback

    Time frame: Week 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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Increasing Women's Engagement in Medication Treatment for Opioid Use Disorder Through Digital Intervention

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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