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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04898478
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

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




Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. 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?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898478


Contacts
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Contact: Andrew Subica 8089369806 asubica@medsch.ucr.edu

Locations
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United States, California
UC Riverside Recruiting
Riverside, California, United States, 91784
Contact: Andrew Subica    808-936-9806    asubica@medsch.ucr.edu   
Sponsors and Collaborators
University of California, Riverside
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Responsible Party: University of California, Riverside
ClinicalTrials.gov Identifier: NCT04898478    
Other Study ID Numbers: R34DA049989 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents