Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder

Early Phase 1

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders

• Registration Number: NCT04898478
• Lead Sponsor: University of California, Riverside

Brief Summary

This study will design and pilot/feasibility test a culturally grounded intervention to increase the treatment seeking of Pacific Islanders with opioid use disorders in formal services.

Detailed Description

For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilot/feasibility test of our conceptual model of culturally grounded intervention components with 20 Pacific Islander adults with experience with opioid use disorders, then conduct 2 focus groups per site to finalize the components and items for larger R01 pilot and randomized wait-list controlled testing.

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-24
• Study Start: 2021-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Of Pacific Islander/Native Hawaiian or part-Pacific Islander/Native Hawaiian heritage.
• Live in Utah or Hawaii.
• For all lay Pacific Islander adult participants: must be over 18 years of age.
• Fluent (oral and reading) in English or Native Hawaiian.

For target Pacific Islander participants with OUDs, additional inclusion criteria is:

• Presence of active OUD, as screened via 8-item Rapid Opioid Dependence Scale.

Exclusion Criteria

• Do not meet inclusion criteria,
• Are unwilling to participate,
• Fails to provide or retracts consent,
• Reside outside the target communities of Utah or Hawaii

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders	Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders	This arm will consist of a behavioral intervention to increase treatment seeking among Pacific Islanders with opioid use disorders.

Primary Outcome Measures

Name	Time	Method
Pacific Islander Knowledge Scale about Opioid Use Disorders and Treatment	Up to 12 months	5-point scale designed by the team to assess Pacific Islander knowledge of opioid use disorder and treatment with items such as "What causes most OUDs? What are the different treatment options for PIs with OUDs"

Secondary Outcome Measures

Name	Time	Method
Pacific Islander Attitude Scale about Opioid Use Disorders and Treatment	Up to 12 months	10-point scale designed by the team to assess Pacific Islander attitudes toward opioid use disorder treatment such as "How important is treatment?" and "How scary is treatment?"

Trial Locations

Locations (1)

UC Riverside; 🇺🇸 Riverside, California, United States