Using Facebook to Support Opioid Recovery Among American Indian Women

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05995886
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 16

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Behavioral: Wiidookaage'win Facebook Group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 2)
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wiidookaage'win Facebook Group The Wiidookaage'win Facebook Group is an online, asynchronous group intervention that will run for 3-months with approximately 30 days of content developed. It is private and hidden, meaning only those in the study will be able to see or find the group. It will be moderated by two women from the study team (one AIAN and one biracial). A back-up moderator will also have access to the group. Participants will be able to comment, react, view, and post in the intervention group, and are encouraged to interact with one another.	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.
No Intervention: Online Resources Landing Page The Online Resources Landing Page was developed by the study team using https://carrd.co. It includes links to local programs in family services, substance use recovery, legal advocacy, etc. which already exist and may help support their recovery.

Outcome Measures

Primary Outcome Measures

1. Feasibility of Facebook Intervention [3 months]

   The study team will measure the feasibility from the combined reports of recruitment, study retention, level of Facebook intervention uptake/engagement, and treatment satisfaction.

Secondary Outcome Measures

1. Timeline Follow-back Interview and UDS to measure Opioid Abstinence [6 months]

   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.

2. Reporting MOUD continuation [6 months]

   The study team will summarize MOUD continuation as the proportion of participants reporting current use at 6-month follow-up.

Other Outcome Measures

1. Perceived Stress Scale and Communal Mastery Scale [3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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,

1. Self-reports at least one month of abstinence from opioid use based on TLFB interview and negative urine opiate screen

2. Current use of MOUD

3. Is comfortable speaking and reading English

4. Has an existing Facebook account or willing to set one up

5. Is willing and able to participate in the Facebook intervention for 3 months

6. Has access to broadband internet on a mobile phone/computer/tablet at any location

7. Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the UDS

8. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mayo Clinic
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Christi A Patten, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05995886
• Other Study ID Numbers: 23-005038; DA40316-08S2
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christi Patten, Professor of Psychology, Mayo Clinic: American Indian or Alaska Native; Internet-based Intervention; Community-based Participatory Research; Minnesota; Ethnic and Racial Minorities; Women's Health
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

No Results Posted as of Aug 16, 2023