Women's Opioid Treatment Follow-up Study

April 7, 2026 updated by: Dawn E. Sugarman, PhD, Mclean Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478-1064
        • Mclean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gender-specific digital intervention plus treatment as usual (GSDI+TAU)
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)
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.
Other: Treatment as usual (TAU)
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after the web-based portion of the intervention, Week 12
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.
12 weeks
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.
Week 1 - Week 12
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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 2, Week 6, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mclean Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023P000495
  • K23DA050780 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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