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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05995886
Other study ID # 23-005038
Secondary ID DA40316-08S2
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2023
Est. completion date December 2024

Study information

Verified date October 2023
Source Mayo Clinic
Contact Antonia M Young, BA
Phone 1-833-880-2600
Email wiidookaagewin@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out whether a Facebook group will help Native women in recovery from opioid use.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. AIAN person based on self-reported race/ethnicity 2. Gender identity as a woman 3. At least 18 years of age with no upper age limit 4. Resides in Minnesota 5. Meets criteria for OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013) 6. Self-reports at least one month of abstinence from opioid use based on TLFB interview and negative urine opiate screen 7. Current use of MOUD 8. Is comfortable speaking and reading English 9. Has an existing Facebook account or willing to set one up 10. Is willing and able to participate in the Facebook intervention for 3 months 11. Has access to broadband internet on a mobile phone/computer/tablet at any location 12. Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the UDS 13. Provides written informed consent Exclusion Criteria: 1. Self-reports current suicidality based on the Concise Heath Risk Tracking scale 2. Participated in prior study phases (Aim 1 formative work) of NIDA CTN-0123

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Wiidookaage'win Facebook Group
An online social media group program that incorporates social support, mindfulness-based, and cultural practices that may support OUD recovery.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Perceived Stress Scale and Communal Mastery Scale The study team will explore the differential impact of the intervention compared with the control condition on constructs targeted by our intervention, specifically perceived stress and coping with stressful life circumstances from a more collectivist orientation, respectively. 3 months
Primary Feasibility of Facebook Intervention The study team will measure the feasibility from the combined reports of recruitment, study retention, level of Facebook intervention uptake/engagement, and treatment satisfaction. 3 months
Secondary Timeline Follow-back Interview and UDS to measure Opioid Abstinence The study team will explore the preliminary differential impact of the intervention compared with the control condition on opioid abstinence and MOUD continuation. Opioid and other substance use will be assessed through monthly Timeline Follow-Back (TLFB) interviews (Sobell & Sobell, 1992; Wray et al., 2016). At 1, 3, and 6-months, the study team will obtain a UDS that will be used along with the TLFB interviews to measure opioid abstinence. 6 months
Secondary Reporting MOUD continuation The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up. 6 months
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