Digital intervention for women with opioid use disorder
Increasing Women's Engagement in Medication Treatment for Opioid Use Disorder Through Digital Intervention
This study is testing a new online support program for women with opioid use disorder to see if it helps them stick with their treatment better than just standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT05776966 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a gender-specific digital intervention for women diagnosed with opioid use disorder. Participants will be randomly assigned to receive either the digital intervention combined with standard treatment or standard treatment alone. The study will measure feasibility, satisfaction, and engagement with the intervention at multiple follow-up points, including post-intervention, two weeks, six weeks, and twelve weeks after enrollment. The goal is to gather preliminary data on how the digital intervention affects engagement in medication treatment for opioid use disorder.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have recently initiated medication treatment for opioid use disorder and own a smartphone.
Not a fit: Patients with acute psychiatric or medical conditions, cognitive impairments, or those admitted involuntarily may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance treatment engagement and outcomes for women with opioid use disorder.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in using digital interventions for substance use disorders, though this specific gender-focused aspect is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Dawn E. Sugarman, PhD
- Email: dsugarman@mclean.harvard.edu
- Phone: 617-855-3650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.