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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Client Satisfaction Questionnaire
Engagement metrics
Qualitative Exit Interview
+1 more
Secondary outcome measures
Timeline Followback

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).

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,654 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,691 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"Affirmative. The information from clinicaltrials.gov highlights the current recruitment status of this investigation. Originally shared on March 8, 2024 and last revised on March 11, 2024, the trial aims to enroll a total of 40 participants at one designated site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Women's Opioid Treatment Follow-up Study
Dawn E. Sugarman, PhD 2024. "Women's Opioid Treatment Follow-up Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776966.
~27 spots leftby Jun 2025
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