Smoking CessationNCT04897607
Precision Pharmacotherapy Smoking Cessation Program
A study testing Precision pharmacotherapy in people with Smoking Cessation, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Precision pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- current smoker (5+ cigarettes/day)
- patient at the Helen F. Graham Cancer Center \& Research Institute (ChristianaCare) lung/thoracic clinic
Who cannot join
- use of non-cigarette tobacco products or smoking cessation treatment
- psychiatric or other medical contraindications to receiving smoking cessation medication
- no telephone
- medical instability
- inability to communicate in English
- unable to consent due to mental status
Show all 9Show fewer
- estimated life expectancy of <6 months
- not a Delaware resident
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen F. Graham Cancer Center & Research Institute
Newark, Delaware, 19713
About this study
Official title: A Pilot Pragmatic RCT of a Hospital-based Precision Pharmacotherapy Smoking Cessation Program
The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.
Read the detailed description
Promising new evidence suggests that applying a precision pharmacotherapy approach based on the nicotine metabolite ration (NMR), a commercially available, genetically-informed marker of nicotine metabolism rate can significantly improve cessation outcomes. Evidence from multiple independent studies, including a recent randomized clinical trial (RCT), demonstrates that matching slow metabolizers of nicotine with the nicotine patch and fast metabolizers of nicotine with varenicline can maximize treatment response and minimize side effects. While encouraging, a critical gap in knowledge is how to best translate a precision pharmacotherapy approach into a hospital-based smoking cessation intervention and improve cessation rates for underserved smokers. Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the scientific premise of this application is that integrating a precision pharmacotherapy approach into a hospital-based smoking cessation program will increase medication uptake and effectiveness, with particular relevance for smokers from underserved communities.
- Conditions
- Smoking Cessation
- Being tested
- Standard Care, Precision pharmacotherapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication.
Precision pharmacotherapyBehavioural
Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Active comparator | Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication. Receives: Behavioral: Standard Care |
| Treatment Plan Option 2 (Precision Pharmacotherapy) | Experimental | Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. Receives: Behavioral: Precision pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieve Smoking Cessation
Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated.
Measured: 4-week follow-up
Secondary outcomes (3)
Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)
Participants will report whether smoking cessation medication was used at the first week follow-up. The percentage of participants who used medication in each arm will be evaluated.
Measured: 1-week follow-up
Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)
Participants will report whether smoking cessation medication was used during 4 week follow up. The percentage of participants who used medication in each arm will be evaluated.
Measured: 4-week follow-up
Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile
Participants will report which smoking cessation medication, if any, was used. Medication usage will be classified as matching their NMR profile as follows: slower metabolizer = nicotine replacement therapy, faster metabolizer = varenicline. The percentage of participants who matched in each arm will be evaluated.
Measured: 1-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start23 Feb 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies 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
- Model description
- Patients will be randomized to the precision or standard care arms in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Scott Siegel, Christiana Care Health Services
- Investigators
- Scott D Siegel, Ph.D., Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897607
- Sponsor's protocol ID
- DDD# 604572
- Other IDs
- U54GM104941, CCC# 41042
- Status last verified
- Mar 2023
- First submitted
- 14 May 2021
- Last updated
- 31 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Pragmatic RCT of a Hospital-based Precision Pharmacotherapy Smoking Cessation Program
- ClinicalTrials.gov ID
- NCT04897607
- Acronym / sponsor ID
- DDD# 604572
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- University of Delaware, National Institute of General Medical Sciences (NIGMS)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.
Detailed description
Promising new evidence suggests that applying a precision pharmacotherapy approach based on the nicotine metabolite ration (NMR), a commercially available, genetically-informed marker of nicotine metabolism rate can significantly improve cessation outcomes. Evidence from multiple independent studies, including a recent randomized clinical trial (RCT), demonstrates that matching slow metabolizers of nicotine with the nicotine patch and fast metabolizers of nicotine with varenicline can maximize treatment response and minimize side effects. While encouraging, a critical gap in knowledge is how to best translate a precision pharmacotherapy approach into a hospital-based smoking cessation intervention and improve cessation rates for underserved smokers. Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the scientific premise of this application is that integrating a precision pharmacotherapy approach into a hospital-based smoking cessation program will increase medication uptake and effectiveness, with particular relevance for smokers from underserved communities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to the precision or standard care arms in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Active comparator | Behavioral: Standard CareStandard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication. |
| Treatment Plan Option 2 (Precision Pharmacotherapy) | Experimental | Behavioral: Precision pharmacotherapyStandard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current smoker (5+ cigarettes/day)
- patient at the Helen F. Graham Cancer Center \& Research Institute (ChristianaCare) lung/thoracic clinic
Key exclusion criteria (9 listed)
- use of non-cigarette tobacco products or smoking cessation treatment
- psychiatric or other medical contraindications to receiving smoking cessation medication
- no telephone
- medical instability
- inability to communicate in English
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 |
|---|---|---|
| Standard CareParticipants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication. | Behavioural | Treatment Plan Option 1 (Standard Care) |
| Precision pharmacotherapyParticipants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication. | Behavioural | Treatment Plan Option 2 (Precision Pharmacotherapy) |
Primary outcome
Number of Participants Who Achieve Smoking Cessation
Time frame: 4-week follow-up
Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated.
3 secondary outcomes
Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)
Time frame: 1-week follow-up
Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)
Time frame: 4-week follow-up
Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile
Time frame: 1-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Using Smartwatches to Monitor Smoking in Real-life Situations
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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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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.
Scott D Siegel, Ph.D. principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision pharmacotherapy in people with Smoking Cessation, run by Christiana Care Health Services 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 31 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Achieve Smoking Cessation (time frame: 4-week follow-up). 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 31 Mar 2023.