Opioid-use DisorderEarly Phase 1NCT04898478
Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
A Early Phase 1 study testing Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders in people with Opioid-use Disorder, run by University of California, Riverside at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Apr 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Do not meet inclusion criteria,
- Are unwilling to participate,
- Fails to provide or retracts consent,
- Reside outside the target communities of Utah or Hawaii
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC Riverside
Riverside, California, 91784
Andrew Subica, 808-936-9806, asubica@medsch.ucr.edu
About this study
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.
Read the 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Seeking Intervention for Pacific Islanders with Opioid Use DisordersBehavioural
The investigators will design a culturally grounded treatment seeking intervention for Pacific Islanders with OUDs
| Study group | Role | What they receive |
|---|---|---|
| Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders | Experimental | This arm will consist of a behavioral intervention to increase treatment seeking among Pacific Islanders with opioid use disorders. Receives: Behavioral: Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Up to 12 months
Secondary outcomes (1)
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?"
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Nov 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898478
- Sponsor's protocol ID
- R34DA049989
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04898478
- Acronym / sponsor ID
- R34DA049989
- Conditions
- Opioid-use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders | Experimental | Behavioral: Treatment Seeking Intervention for Pacific Islanders with Opioid Use DisordersThis arm will consist of a behavioral intervention to increase treatment seeking among Pacific Islanders with opioid use disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Presence of active OUD, as screened via 8-item Rapid Opioid Dependence Scale.
Key exclusion criteria (4 listed)
- Do not meet inclusion criteria,
- Are unwilling to participate,
- Fails to provide or retracts consent,
- Reside outside the target communities of Utah or Hawaii
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Seeking Intervention for Pacific Islanders with Opioid Use DisordersThe investigators will design a culturally grounded treatment seeking intervention for Pacific Islanders with OUDs | Behavioural | Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders |
Primary outcome
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"
1 secondary outcome
Pacific Islander Attitude Scale about Opioid Use Disorders and Treatment
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders in people with Opioid-use Disorder, run by University of California, Riverside at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Subica (8089369806, asubica@medsch.ucr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pacific Islander Knowledge Scale about Opioid Use Disorders and Treatment (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.