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Digital Program for Women with Opioid Use Disorder

N/A

Recruiting

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 6, week 12

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new digital program tailored for women with opioid addiction. Women in the study will either receive the digital program along with their usual treatment, or just their usual treatment. Researchers will

Who is the study for?

This trial is for women over 18 with an opioid use disorder who have started medication treatment in the last 10 days. Participants must own a smartphone and be able to give informed consent.

What is being tested?

The study tests a gender-specific digital intervention (GSDI) alongside usual treatment for opioid use disorder versus usual treatment alone. It measures how well the digital tool works, how satisfied participants are, and their level of engagement.

What are the potential side effects?

Since this trial involves a digital intervention rather than medication, traditional side effects are not applicable. However, there may be emotional or psychological impacts from engaging with the content.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 6, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, week 6, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 6, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Client Satisfaction Questionnaire

Engagement metrics

Qualitative Exit Interview

+1 more

Secondary study objectives

Timeline Followback

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment as usual (TAU)Experimental Treatment1 Intervention

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.

Group II: Gender-specific digital intervention plus treatment as usual (GSDI+TAU)Experimental Treatment2 Interventions

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).

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