Tobacco Use DisorderNCT07075575
Quit-Smoking Study for Native Hawaiians
A study testing Nicotine Polacrilex Gum (2 mg) and Cognitive Behavioral Group Therapy (CBGT) in people with Tobacco Use Disorder and Smoking Cessation, run by University of Hawaii at 1 site in United States.
Trial summary
This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation
- What is being tested?
- Nicotine Polacrilex Gum (2 mg) and Cognitive Behavioral Group Therapy (CBGT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as full or part Native Hawaiian
- Between the ages of 18 and 80 years, inclusive, at eligibility screening
- Currently smoking ≥5 cigarettes per day (self-report) at eligibility screening
- Has smoked more than 100 cigarettes in his/her lifetime (self-report)
- Affiliated with one of three (3) designated public housing complexes at which the intervention will be delivered: Kalihi Valley Homes, Kuhio Park Terrace, Mayor Wright Housing
- Willing to make a smoking cessation attempt the day after the first study visit (i.e., date of consent)
Show all 13Show fewer
- Willing to engage in use of nicotine replacement therapy gum (NRT gum) and/or smoking cessation-focused cognitive-behavioral group therapy (CBGT)
- Participant must agree to not use any form of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking during the 12-week study period, except as specifically assigned to his or her study condition and distributed by the research team
- Participant must agree to not use other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) during the 12-week study period
- Participant must agree to not smoke or vape cannabis (i.e., marijuana) during the 12- week study period
- Participant must agree to not use other illicit drugs, including prescription opioid medications, during the 12-week study period
- Participant must be able to speak, read, and write English
- Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
Who cannot join
- Pregnant or nursing, or planning to become pregnant or breastfeed in the next three (3) months
- Use of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking in the 30 days prior to eligibility screening
- Use of other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) in the 30 days prior to eligibility screening
- Use of smoked or vaped cannabis (i.e., marijuana) in the 30 days prior to eligibility screening
- Use of other illicit drugs, including prescription opioid medications, in the 30 days prior to eligibility screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Hawai'i
Honolulu, Hawaii, 96813
Pallav Pokhrel, PhD, MPH, 8084417711, ppokhrel@cc.hawaii.edu
About this study
Official title: Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling
This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Being tested
- Nicotine Polacrilex Gum (2 mg), Cognitive Behavioral Group Therapy (CBGT)
- Keywords
- Native Hawaiian, Smoking cessation, Nicotine replacement therapy, Nicotine gum, Cigarette Smoking, Tobacco Dependence
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Polacrilex Gum (2 mg)Drug
Participants chew 2 mg nicotine gum according to a tapering 12-week schedule: Weeks 1-6: 1 piece every 1-2 hours; at least 9 pieces/day; Weeks 7-9: 1 piece every 2-4 hours; Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces/day. Gum is distributed every 2 weeks during study visits.
Arm(s) Used In:
NRT Gum Only CBGT + NRT Gum
Cognitive Behavioral Group Therapy (CBGT)Behavioural
Participants attend six sessions of group-based cognitive behavioral therapy focused on smoking cessation, over the 12-week study period. Sessions include education on cravings, relapse prevention, stress management, and self-efficacy building.
Arm(s) Used In:
CBGT Only CBGT + NRT Gum
| Study group | Role | What they receive |
|---|---|---|
| NRT Gum Only | Experimental | Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided. Receives: Drug: Nicotine Polacrilex Gum (2 mg) |
| CBGT Only | Experimental | Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided. Receives: Behavioral: Cognitive Behavioral Group Therapy (CBGT) |
| CBGT + NRT Gum | Experimental | Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation. Receives: Drug: Nicotine Polacrilex Gum (2 mg); Behavioral: Cognitive Behavioral Group Therapy (CBGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence (PPA)
Self-reported 7-day point prevalence abstinence from cigarette smoking, confirmed by exhaled carbon monoxide (eCO) <10 ppm at final follow-up visit.
Measured: 12 weeks after baseline (Study Visit 8)
Secondary outcomes (3)
Change in nicotine dependence
Change in nicotine dependence scores as measured by standardized tools (e.g., Fagerström Test for Nicotine Dependence).
Measured: Baseline to 12 weeks
Change in smoking self-efficacy
Change in participants' confidence in their ability to quit smoking, measured using a validated smoking self-efficacy scale.
Measured: Baseline to 12 weeks
Number of adverse events
Frequency and severity of adverse events related to nicotine gum or study procedures, as reported by participants or observed by study staff.
Measured: Throughout the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Tobacco 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crissy T Kawamoto, Study director, University of Hawai'i Cancer CenterPallav Pokhrel, PhD, MPH, Principal investigator, University of Hawai'i Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075575
- Sponsor's protocol ID
- POKHREL-2024-1
- Status last verified
- Mar 2026
- First submitted
- 10 Jul 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Webb MS, de Ybarra DR, Baker EA, Reis IM, Carey MP. Cognitive-behavioral therapy to promote smoking cessation among African American smokers: a randomized clinical trial. J Consult Clin Psychol. 2010 Feb;78(1):24-33. doi: 10.1037/a0017669.
PubMed 20099947Stead LF, Carroll AJ, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD001007. doi: 10.1002/14651858.CD001007.pub3.
PubMed 28361497Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.
PubMed 27658756Ong JC, Kuo TF, Manber R. Who is at risk for dropout from group cognitive-behavior therapy for insomnia? J Psychosom Res. 2008 Apr;64(4):419-25. doi: 10.1016/j.jpsychores.2007.10.009.
PubMed 18374742Nevid JS, Javier RA. Preliminary investigation of a culturally specific smoking cessation intervention for Hispanic smokers. Am J Health Promot. 1997 Jan-Feb;11(3):198-207. doi: 10.4278/0890-1171-11.3.198.
PubMed 10165099Meredith SE, Grabinski MJ, Dallery J. Internet-based group contingency management to promote abstinence from cigarette smoking: a feasibility study. Drug Alcohol Depend. 2011 Oct 1;118(1):23-30. doi: 10.1016/j.drugalcdep.2011.02.012. Epub 2011 Mar 16.
PubMed 21414733Lo Coco G, Melchiori F, Oieni V, Infurna MR, Strauss B, Schwartze D, Rosendahl J, Gullo S. Group treatment for substance use disorder in adults: A systematic review and meta-analysis of randomized-controlled trials. J Subst Abuse Treat. 2019 Apr;99:104-116. doi: 10.1016/j.jsat.2019.01.016. Epub 2019 Jan 24.
PubMed 30797382Lee PN, Fariss MW. A systematic review of possible serious adverse health effects of nicotine replacement therapy. Arch Toxicol. 2017 Apr;91(4):1565-1594. doi: 10.1007/s00204-016-1856-y. Epub 2016 Oct 3.
PubMed 27699443Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD001292. doi: 10.1002/14651858.CD001292.pub3.
PubMed 28361496Hunt DF, Bailey J, Lennox BR, Crofts M, Vincent C. Enhancing psychological safety in mental health services. Int J Ment Health Syst. 2021 Apr 14;15(1):33. doi: 10.1186/s13033-021-00439-1.
PubMed 33853658Hiscock R, Murray S, Brose LS, McEwen A, Bee JL, Dobbie F, Bauld L. Behavioural therapy for smoking cessation: the effectiveness of different intervention types for disadvantaged and affluent smokers. Addict Behav. 2013 Nov;38(11):2787-96. doi: 10.1016/j.addbeh.2013.07.010. Epub 2013 Jul 21.
PubMed 23954946Goldstein AO, Gans SP, Ripley-Moffitt C, Kotsen C, Bars M. Use of Expired Air Carbon Monoxide Testing in Clinical Tobacco Treatment Settings. Chest. 2018 Feb;153(2):554-562. doi: 10.1016/j.chest.2017.11.002. Epub 2017 Nov 11.
PubMed 29137909Gifford EV, Kohlenberg BS, Hayes SC, Pierson HM, Piasecki MP, Antonuccio DO, Palm KM. Does acceptance and relationship focused behavior therapy contribute to bupropion outcomes? A randomized controlled trial of functional analytic psychotherapy and acceptance and commitment therapy for smoking cessation. Behav Ther. 2011 Dec;42(4):700-15. doi: 10.1016/j.beth.2011.03.002. Epub 2011 May 25.
PubMed 22035998Creamer MR, Wang TW, Babb S, Cullen KA, Day H, Willis G, Jamal A, Neff L. Tobacco Product Use and Cessation Indicators Among Adults - United States, 2018. MMWR Morb Mortal Wkly Rep. 2019 Nov 15;68(45):1013-1019. doi: 10.15585/mmwr.mm6845a2.
PubMed 31725711
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling
- ClinicalTrials.gov ID
- NCT07075575
- Acronym / sponsor ID
- POKHREL-2024-1
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Keywords
- Native Hawaiian, Smoking cessation, Nicotine replacement therapy, Nicotine gum, Cigarette Smoking, Tobacco Dependence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Jul 2025 (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 aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NRT Gum Only | Experimental | Drug: Nicotine Polacrilex Gum (2 mg)Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided. |
| CBGT Only | Experimental | Behavioral: Cognitive Behavioral Group Therapy (CBGT)Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided. |
| CBGT + NRT Gum | Experimental | Drug: Nicotine Polacrilex Gum (2 mg), Behavioral: Cognitive Behavioral Group Therapy (CBGT)Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Self-identifies as full or part Native Hawaiian
- Between the ages of 18 and 80 years, inclusive, at eligibility screening
- Currently smoking ≥5 cigarettes per day (self-report) at eligibility screening
- Has smoked more than 100 cigarettes in his/her lifetime (self-report)
- Affiliated with one of three (3) designated public housing complexes at which the intervention will be delivered: Kalihi Valley Homes, Kuhio Park Terrace, Mayor Wright Housing
Key exclusion criteria (5 listed)
- Pregnant or nursing, or planning to become pregnant or breastfeed in the next three (3) months
- Use of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking in the 30 days prior to eligibility screening
- Use of other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) in the 30 days prior to eligibility screening
- Use of smoked or vaped cannabis (i.e., marijuana) in the 30 days prior to eligibility screening
- Use of other illicit drugs, including prescription opioid medications, in the 30 days prior to eligibility screening
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 |
|---|---|---|
| Nicotine Polacrilex Gum (2 mg)Participants chew 2 mg nicotine gum according to a tapering 12-week schedule: Weeks 1-6: 1 piece every 1-2 hours; at least 9 pieces/day; Weeks 7-9: 1 piece every 2-4 hours; Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces/day. Gum is distributed every 2 weeks during study visits. Arm(s) Used In: NRT Gum Only CBGT + NRT Gum | Drug | CBGT + NRT Gum, NRT Gum Only |
| Cognitive Behavioral Group Therapy (CBGT)Participants attend six sessions of group-based cognitive behavioral therapy focused on smoking cessation, over the 12-week study period. Sessions include education on cravings, relapse prevention, stress management, and self-efficacy building. Arm(s) Used In: CBGT Only CBGT + NRT Gum | Behavioural | CBGT + NRT Gum, CBGT Only |
Primary outcome
7-day point prevalence abstinence (PPA)
Time frame: 12 weeks after baseline (Study Visit 8)
Self-reported 7-day point prevalence abstinence from cigarette smoking, confirmed by exhaled carbon monoxide (eCO) <10 ppm at final follow-up visit.
3 secondary outcomes
Change in nicotine dependence
Time frame: Baseline to 12 weeks
Change in smoking self-efficacy
Time frame: Baseline to 12 weeks
Number of adverse events
Time frame: Throughout the 12-week intervention period
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 31 Mar 2026.
- Results publication: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Results publication: PubMed 20099947Webb MS, de Ybarra DR, Baker EA, Reis IM, Carey MP. Cognitive-behavioral therapy to promote smoking cessation among African American smokers: a randomized clinical trial. J Consult Clin Psychol. 2010 Feb;78(1):24-33. doi: 10.1037/a0017669.
- Results publication: PubMed 28361497Stead LF, Carroll AJ, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD001007. doi: 10.1002/14651858.CD001007.pub3.
- Results publication: PubMed 27658756Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.
- Results publication: PubMed 18374742Ong JC, Kuo TF, Manber R. Who is at risk for dropout from group cognitive-behavior therapy for insomnia? J Psychosom Res. 2008 Apr;64(4):419-25. doi: 10.1016/j.jpsychores.2007.10.009.
- Results publication: PubMed 10165099Nevid JS, Javier RA. Preliminary investigation of a culturally specific smoking cessation intervention for Hispanic smokers. Am J Health Promot. 1997 Jan-Feb;11(3):198-207. doi: 10.4278/0890-1171-11.3.198.
- Results publication: PubMed 21414733Meredith SE, Grabinski MJ, Dallery J. Internet-based group contingency management to promote abstinence from cigarette smoking: a feasibility study. Drug Alcohol Depend. 2011 Oct 1;118(1):23-30. doi: 10.1016/j.drugalcdep.2011.02.012. Epub 2011 Mar 16.
- Results publication: PubMed 30797382Lo Coco G, Melchiori F, Oieni V, Infurna MR, Strauss B, Schwartze D, Rosendahl J, Gullo S. Group treatment for substance use disorder in adults: A systematic review and meta-analysis of randomized-controlled trials. J Subst Abuse Treat. 2019 Apr;99:104-116. doi: 10.1016/j.jsat.2019.01.016. Epub 2019 Jan 24.
- Results publication: PubMed 27699443Lee PN, Fariss MW. A systematic review of possible serious adverse health effects of nicotine replacement therapy. Arch Toxicol. 2017 Apr;91(4):1565-1594. doi: 10.1007/s00204-016-1856-y. Epub 2016 Oct 3.
- Results publication: PubMed 28361496Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD001292. doi: 10.1002/14651858.CD001292.pub3.
- Results publication: PubMed 33853658Hunt DF, Bailey J, Lennox BR, Crofts M, Vincent C. Enhancing psychological safety in mental health services. Int J Ment Health Syst. 2021 Apr 14;15(1):33. doi: 10.1186/s13033-021-00439-1.
- Results publication: PubMed 23954946Hiscock R, Murray S, Brose LS, McEwen A, Bee JL, Dobbie F, Bauld L. Behavioural therapy for smoking cessation: the effectiveness of different intervention types for disadvantaged and affluent smokers. Addict Behav. 2013 Nov;38(11):2787-96. doi: 10.1016/j.addbeh.2013.07.010. Epub 2013 Jul 21.
- General consumer information about nicotine gum, including proper use, precautions, and side effects. Provided by MedlinePlus, a service of the U.S. National Library of Medicine.Link provided by the sponsor.
- Strategic plan from the Hawai'i State Department of Health outlining goals and priorities for tobacco prevention and control across the state, including culturally tailored interventions for Native Hawaiians and other priority populations.Link provided by the sponsor.
- Behavioral Risk Factor Surveillance System (BRFSS) data from the Hawai'i Health Data Warehouse showing smoking prevalence among adults by race/ethnicity from 2018-2023. Useful for understanding disparities in tobacco use among Native Hawaiians and otherLink provided by the sponsor.
- Summary report from the Hawai'i Tumor Registry presenting cancer incidence and mortality data in Hawai'i from 2014-2018. Includes statistics by race/ethnicity and geographic region, supporting local relevance of tobacco-related cancer prevention.Link provided by the sponsor.
- ICH E2A guideline outlining international standards for defining, collecting, and reporting clinical safety data, including serious adverse events (SAEs) and expedited reporting procedures.Link provided by the sponsor.
- Guidelines from the National Cancer Institute (NCI) detailing adverse event reporting requirements for investigators conducting studies under NCI's Division of Cancer Treatment and Diagnosis (DCTD) and Division of Cancer Prevention (DCP) INDs and IDEs.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Crissy T Kawamoto study director
University of Hawai'i Cancer Center
Pallav Pokhrel, PhD, MPH principal investigator
University of Hawai'i Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Polacrilex Gum (2 mg) and Cognitive Behavioral Group Therapy (CBGT) in people with Tobacco Use Disorder and Smoking Cessation, run by University of Hawaii 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 13 inclusion and 5 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 31 Mar 2026. 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 Pallav Pokhrel, PhD, MPH (808-441-7711, ppokhrel@cc.hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (PPA) (time frame: 12 weeks after baseline (Study Visit 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075575, which also lists 17 linked publications.
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 31 Mar 2026.