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

Primary Purpose

Opioid-use Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders
Sponsored by
University of California, Riverside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC RiversideRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders

Arm Description

This arm will consist of a behavioral intervention to increase treatment seeking among Pacific Islanders with opioid use disorders.

Outcomes

Primary Outcome Measures

Pacific Islander Knowledge Scale about Opioid Use Disorders and Treatment
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

Pacific Islander Attitude Scale about Opioid Use Disorders and Treatment
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?"

Full Information

First Posted
April 13, 2021
Last Updated
June 8, 2022
Sponsor
University of California, Riverside
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1. Study Identification

Unique Protocol Identification Number
NCT04898478
Brief Title
Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
Official Title
Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Riverside

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders
Arm Type
Experimental
Arm Description
This arm will consist of a behavioral intervention to increase treatment seeking among Pacific Islanders with opioid use disorders.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders
Intervention Description
The investigators will design a culturally grounded treatment seeking intervention for Pacific Islanders with OUDs
Primary Outcome Measure Information:
Title
Pacific Islander Knowledge Scale about Opioid Use Disorders and Treatment
Description
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"
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Pacific Islander Attitude Scale about Opioid Use Disorders and Treatment
Description
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?"
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Subica
Phone
8089369806
Email
asubica@medsch.ucr.edu
Facility Information:
Facility Name
UC Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
91784
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Subica
Phone
808-936-9806
Email
asubica@medsch.ucr.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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