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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898478
• Other study ID #: R34DA049989
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: April 2022
• Source: University of California, Riverside
• Contact: Andrew Subica
• Phone: 8089369806
• Email: asubica[@]medsch.ucr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	UC Riverside	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Riverside

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	Up to 12 months
Secondary	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?"	Up to 12 months