Women's Opioid Treatment Follow-up Study

NCT05776966 | Completed

• 2 other identifiers: 2023P000495K23DA050780
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (4)

• Client Satisfaction Questionnaire

  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.

  Immediately after the web-based portion of the intervention, Week 12

• System Usability Scale

  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.

  12 weeks

• Engagement metrics

  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.

  Week 1 - Week 12

• Qualitative Exit Interview

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

  Week 12

Secondary Outcomes (1)

• Timeline Followback

  Week 2, Week 6, Week 12

Study Arms (2)

Gender-specific digital intervention plus treatment as usual (GSDI+TAU)

EXPERIMENTAL

GSDI + TAU includes the addition of a gender-specific digital intervention (GSDI) to treatment as usual. The GSDI has a web-based component and a mobile component. The web-based portion of the GSDI includes: (1) gender-specific psychoeducation on substance use disorders, (2) specific education on opioid use disorder, including information about medication treatment for opioid use disorder, and (3) information on relapse-prevention skills. Participants complete the web-based portion immediately after completing baseline assessments. The mobile component includes three parts: (1) weekly self-report surveys of opioid and other substance use and medication adherence, (2) weekly skills-practice exercises, and (3) daily motivational messages encouraging self-care. Participants engage with the mobile component after completing the web-based portion until the end of the study (12 weeks).

Behavioral: Gender-specific digital intervention (GSDI); Other: Treatment as usual

Treatment as usual (TAU)

OTHER

TAU for opioid use disorder consists of a mix of medication treatment and individual and group therapy services across various levels of care: inpatient, residential, and outpatient. Residential treatment is for adults who have completed detoxification and require additional treatment in a structured environment. Inpatient treatment includes short-term care and detoxification treatment and incorporates a combination of group, family, and individual therapy targeted at medical stabilization, reducing the severity of the patient's symptoms, and providing resources and ongoing support to prevent relapse. Outpatient treatment is focused on comprehensive evaluation and stabilization.

Other: Treatment as usual

Interventions

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.

Gender-specific digital intervention plus treatment as usual (GSDI+TAU)

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.

Gender-specific digital intervention plus treatment as usual (GSDI+TAU); Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to the gender-specific focus of this study, only participants who do identify as women will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478-1064, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 8, 2024
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)