Alcohol Use DisorderNCT06337721
Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
A study testing SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) in people with Alcohol Use Disorder and Alcohol; Harmful Use, run by University of California, Riverside at 1 site in United States.
Trial summary
This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol; Harmful Use
- What is being tested?
- SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Of full or part self-reported Pacific Islander heritage;
- Fluent (oral and reading) in English
- For young adult participants: 18 - 30 years of age
- Current drinking (1+ drink in past 30 days)
- High AUD risk (AUDIT-C score # 4 for men, # 3 for women)
- Not currently in alcohol treatment (medication, therapeutic).
Who cannot join
- Do not meet inclusion criteria
- Are unwilling to participate
- Fail to provide or retracts consent
- Reside outside the target Pacific Islander communities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT).
Read the detailed description
Pacific Islander young adults bear elevated risk for alcohol use disorders (AUD) and alcohol-related harms, yet lack effective interventions to reduce their risk. Grounded in the social development model, this study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults from existing evidence-based AUD prevention strategies; then (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT) with at-risk Pacific Islander young adults across multiple Pacific Islander communities in the US.
- Conditions
- Alcohol Use Disorder, Alcohol; Harmful Use
- Being tested
- SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)Behavioural
This behavioral group intervention will consist of multiple group sessions to reduce AUDs and alcohol-related harms in Pacific Islander young adults. It will infuse culturally resonant narratives, language, and elements into existing evidence-based strategies.
| Study group | Role | What they receive |
|---|---|---|
| SPEAR | Experimental | This arm will consist of the SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) behavioral group intervention to reduce AUDs and alcohol-related harms in Pacific Islander young adults. Receives: Behavioral: SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) |
| Control | No intervention | This control group arm will be compared to the SPEAR intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy Episodic Drinking (HED) Days
# of Days of HED out of past 30 days
Measured: Up to 30 weeks
Secondary outcomes (1)
Alcohol Consumption
7-day Alcohol Consumption
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study startSep 2024 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Will conduct a randomized controlled trial of the SPEAR intervention vs. control group.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANDREW SUBICA, Principal investigator, UC Riverside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337721
- Sponsor's protocol ID
- R01AA030786
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
- ClinicalTrials.gov ID
- NCT06337721
- Acronym / sponsor ID
- R01AA030786
- Conditions
- Alcohol Use Disorder, Alcohol; Harmful Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Mar 2024 (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: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT).
Detailed description
Pacific Islander young adults bear elevated risk for alcohol use disorders (AUD) and alcohol-related harms, yet lack effective interventions to reduce their risk. Grounded in the social development model, this study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults from existing evidence-based AUD prevention strategies; then (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT) with at-risk Pacific Islander young adults across multiple Pacific Islander communities in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Will conduct a randomized controlled trial of the SPEAR intervention vs. control group.
| Arm | Type | Receives |
|---|---|---|
| SPEAR | Experimental | Behavioral: SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)This arm will consist of the SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) behavioral group intervention to reduce AUDs and alcohol-related harms in Pacific Islander young adults. |
| Control | No intervention | –This control group arm will be compared to the SPEAR intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Of full or part self-reported Pacific Islander heritage;
- Fluent (oral and reading) in English
- For young adult participants: 18 - 30 years of age
- Current drinking (1+ drink in past 30 days)
- High AUD risk (AUDIT-C score # 4 for men, # 3 for women)
Key exclusion criteria (4 listed)
- Do not meet inclusion criteria
- Are unwilling to participate
- Fail to provide or retracts consent
- Reside outside the target Pacific Islander communities
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 |
|---|---|---|
| SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction)This behavioral group intervention will consist of multiple group sessions to reduce AUDs and alcohol-related harms in Pacific Islander young adults. It will infuse culturally resonant narratives, language, and elements into existing evidence-based strategies. | Behavioural | SPEAR |
Primary outcome
Heavy Episodic Drinking (HED) Days
Time frame: Up to 30 weeks
# of Days of HED out of past 30 days
1 secondary outcome
Alcohol Consumption
Time frame: Up to 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
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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.
ANDREW SUBICA principal investigator
UC Riverside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) in people with Alcohol Use Disorder and Alcohol; Harmful Use, 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: opening soon, as of the sponsor's last update on 29 Mar 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ANDREW SUBICA, Ph.D. ((951) 827-0200, asubica@medsch.ucr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy Episodic Drinking (HED) Days (time frame: Up to 30 weeks). 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 29 Mar 2024.