Women's Opioid Treatment Follow-up Study

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776966
• Other study ID #: 2023P000495
• Secondary ID: K23DA050780
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: Dawn E. Sugarman, PhD
• Phone: 617-855-3650
• Email: dsugarman[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• Gender-specific digital intervention (GSDI)
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.

Other:
• Treatment as usual
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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Qualitative Exit Interview	Qualitative user experience exit interviews will be coded and analyzed using thematic analysis methodology to identify common themes.	Week 12
Secondary	Timeline Followback	The Timeline Followback calendar method will be used to collect self-report data on medication for opioid use disorder adherence.	Week 2, Week 6, Week 12