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

June 8, 2022 updated by: University of California, Riverside
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Riverside, California, United States, 91784
        • Recruiting
        • UC Riverside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders
The investigators will design a culturally grounded treatment seeking intervention for Pacific Islanders with OUDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pacific Islander Knowledge Scale about Opioid Use Disorders and Treatment
Time Frame: 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"
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pacific Islander Attitude Scale about Opioid Use Disorders and Treatment
Time Frame: 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?"
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Riverside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2021

Primary Completion (ANTICIPATED)

April 30, 2023

Study Completion (ANTICIPATED)

April 30, 2023

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (ACTUAL)

May 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34DA049989 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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