Betel Nut CessationEarly Phase 1NCT05758298
Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan
A Early Phase 1 study testing Non-medicated gum, NICOTINE 2MG GUM and NICOTINE 4MG GUM in people with Betel Nut Cessation, run by University of Texas Southwestern Medical Center.
Trial summary
The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Betel Nut Cessation
- What is being tested?
- Non-medicated gum, NICOTINE 2MG GUM and NICOTINE 4MG GUM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Dec 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Daily betel nut chewers who use betel nut and tobacco in their chews.
- Interested in betel nut reduction or cessation when they are informed of the study.
- Must chew greater than or equal to 4 times a day.
- Must have an appointment with a provider at the Commonwealth Healthcare Corporation
Who cannot join
- Tobacco smokers
- Under the age of 18 years old
- Potential subjects unable to accurately estimate the number of average betel nut chews per day (will be able to re-present for enrollment if they are able to make an accurate estimate of chews per day after keeping a personal record chew for one week or more)
- Pregnant patients
- Established diagnosis of oropharyngeal cancer
About this study
The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their chew. One of the study team members will be traveling to Commonwealth of Northern Mariana Islands and a letter of support has been obtained in order to conduct the study.
Eligible patients must be non-tobacco smokers, be actively interested in betel nut reduction or cessation, and chew at least four times a day on average. Subjects will be randomized equally into three distinct groups for the purpose of this study:
- non-medicated regular chewing gum
- nicotine 2 mg gum
- nicotine 4 mg gum
Read the detailed description
Objectives include:
- Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.
- Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.
- Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.
- Conditions
- Betel Nut Cessation
- Being tested
- Non-medicated gum, NICOTINE 2MG GUM, NICOTINE 4MG GUM
- Keywords
- replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-medicated gumOther
Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
NICOTINE 2MG GUMDrug
Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
NICOTINE 4MG GUMDrug
Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
| Study group | Role | What they receive |
|---|---|---|
| Non-medicated gum Arm | Placebo comparator | Participants in this group will receive the non-medicated gum in mint flavor. Receives: Other: Non-medicated gum |
| Nicotine 2mg gum Arm | Experimental | Participants in this group will receive the 2mg Nicotine gum in mint flavor. Receives: Drug: NICOTINE 2MG GUM |
| Nicotine 4mg gum Arm | Experimental | Participants in this group will receive the 4mg Nicotine gum in mint flavor. Receives: Drug: NICOTINE 4MG GUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average "betel nut chews per day" at 3 months
Average "betel nut chews per day" will be calculated by taking average of one full week of self-reported daily chews
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Oct 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: Have not received IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Betel Nut CessationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Commonwealth Healthcare Corporation
- Responsible party
- Principal investigator, Mary Chang, University of Texas Southwestern Medical Center
- Investigators
- Mary Chang, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758298
- Sponsor's protocol ID
- STU-2022-1040
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan
- ClinicalTrials.gov ID
- NCT05758298
- Acronym / sponsor ID
- STU-2022-1040
- Conditions
- Betel Nut Cessation
- Keywords
- replacement therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Have not received IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Commonwealth Healthcare Corporation
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 Mar 2023 (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.
The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their chew. One of the study team members will be traveling to Commonwealth of Northern Mariana Islands and a letter of support has been obtained in order to conduct the study.
Eligible patients must be non-tobacco smokers, be actively interested in betel nut reduction or cessation, and chew at least four times a day on average. Subjects will be randomized equally into three distinct groups for the purpose of this study:
- non-medicated regular chewing gum
- nicotine 2 mg gum
- nicotine 4 mg gum
Detailed description
Objectives include:
- Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.
- Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.
- Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-medicated gum Arm | Placebo comparator | Other: Non-medicated gumParticipants in this group will receive the non-medicated gum in mint flavor. |
| Nicotine 2mg gum Arm | Experimental | Drug: NICOTINE 2MG GUMParticipants in this group will receive the 2mg Nicotine gum in mint flavor. |
| Nicotine 4mg gum Arm | Experimental | Drug: NICOTINE 4MG GUMParticipants in this group will receive the 4mg Nicotine gum in mint flavor. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Daily betel nut chewers who use betel nut and tobacco in their chews.
- Interested in betel nut reduction or cessation when they are informed of the study.
- Must chew greater than or equal to 4 times a day.
- Must have an appointment with a provider at the Commonwealth Healthcare Corporation
Key exclusion criteria (5 listed)
- Tobacco smokers
- Under the age of 18 years old
- Potential subjects unable to accurately estimate the number of average betel nut chews per day (will be able to re-present for enrollment if they are able to make an accurate estimate of chews per day after keeping a personal record chew for one week or more)
- Pregnant patients
- Established diagnosis of oropharyngeal cancer
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 |
|---|---|---|
| Non-medicated gumNon-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed). | Other | Non-medicated gum Arm |
| NICOTINE 2MG GUMNicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed). | Drug | Nicotine 2mg gum Arm |
| NICOTINE 4MG GUMNicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed). | Drug | Nicotine 4mg gum Arm |
Primary outcome
Change in average "betel nut chews per day" at 3 months
Time frame: Baseline, 3 months
Average "betel nut chews per day" will be calculated by taking average of one full week of self-reported daily chews
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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.
Mary Chang, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Non-medicated gum, NICOTINE 2MG GUM and NICOTINE 4MG GUM in people with Betel Nut Cessation, run by University of Texas Southwestern Medical Center.
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 4 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: withdrawn, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average "betel nut chews per day" at 3 months (time frame: Baseline, 3 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 7 Sep 2023.