Smoking Cessation
Conditions
Brief 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 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.
Interventions
BEHAVIORALStandard Care
Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication.
BEHAVIORALPrecision pharmacotherapy
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.
Sponsors
University of Delaware
National Institute of General Medical Sciences (NIGMS)
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to the precision or standard care arms in a 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* current smoker (5+ cigarettes/day) * patient at the Helen F. Graham Cancer Center & Research Institute (ChristianaCare) lung/thoracic clinic
Exclusion criteria
* 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 * estimated life expectancy of \<6 months * not a Delaware resident * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieve Smoking Cessation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week) | 1-week follow-up | 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. |
| Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week) | 4-week follow-up | 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. |
| Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile | 1-week follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Plan Option 1 (Standard Care) Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication.
Standard Care: Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication. | 17 |
| Treatment Plan Option 2 (Precision Pharmacotherapy) 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.
Precision pharmacotherapy: 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. | 20 |
| Total | 37 |
Baseline characteristics
| Characteristic | Treatment Plan Option 1 (Standard Care) | Treatment Plan Option 2 (Precision Pharmacotherapy) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 14 Participants | 23 Participants |
| Age, Continuous | 60.88 years STANDARD_DEVIATION 7.01 | 59.42 years STANDARD_DEVIATION 9.64 | 60.03 years STANDARD_DEVIATION 8.9 |
| Count of Active Smokers | 17 Participants | 20 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment United States | 17 participants | 20 participants | 37 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 1 / 20 |
| other Total, other adverse events | 0 / 17 | 1 / 20 |
| serious Total, serious adverse events | 0 / 17 | 1 / 20 |
Outcome results
Primary
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.
Time frame: 4-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Number of Participants Who Achieve Smoking Cessation | 1 Participants |
| Treatment Plan Option 2 (Precision Pharmacotherapy) | Number of Participants Who Achieve Smoking Cessation | 1 Participants |
Secondary
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.
Time frame: 1-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile | 5 Participants |
| Treatment Plan Option 2 (Precision Pharmacotherapy) | Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile | 11 Participants |
Secondary
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.
Time frame: 1-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week) | 11 Participants |
| Treatment Plan Option 2 (Precision Pharmacotherapy) | Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week) | 14 Participants |
Secondary
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.
Time frame: 4-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week) | 4 Participants |
| Treatment Plan Option 2 (Precision Pharmacotherapy) | Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week) | 6 Participants |