Trial Outcomes & Findings for Precision Pharmacotherapy Smoking Cessation Program (NCT NCT04897607)
NCT ID: NCT04897607
Last Updated: 2023-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
4-week follow-up
Results posted on
2023-03-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Precision Pharmacotherapy Smoking Cessation Program
Baseline characteristics by cohort
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 Participants
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
60.88 years
STANDARD_DEVIATION 7.01 • n=5 Participants
|
59.42 years
STANDARD_DEVIATION 9.64 • n=7 Participants
|
60.03 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Count of Active Smokers
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-week follow-upParticipants 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.
Outcome measures
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 Participants
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Who Achieve Smoking Cessation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-week follow-upParticipants 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.
Outcome measures
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 Participants
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 4-week follow-upParticipants 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.
Outcome measures
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 Participants
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-week follow-upParticipants 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.
Outcome measures
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 Participants
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile
|
5 Participants
|
11 Participants
|
Adverse Events
Treatment Plan Option 1 (Standard Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Plan Option 2 (Precision Pharmacotherapy)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 participants at risk
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
Pre-existing diabetes
|
0.00%
0/17 • General recruitment began in February 2022 - December 2022 (approximately 10 months). Patients who were enrolled received an initial baseline intake survey followed by appointments one week (Week 1) and four weeks (Week 4) after beginning their medication. Patient data for adverse events were collected during the patient's entire enrollment (approximately 6 weeks).
|
5.0%
1/20 • General recruitment began in February 2022 - December 2022 (approximately 10 months). Patients who were enrolled received an initial baseline intake survey followed by appointments one week (Week 1) and four weeks (Week 4) after beginning their medication. Patient data for adverse events were collected during the patient's entire enrollment (approximately 6 weeks).
|
Other adverse events
| Measure |
Treatment Plan Option 1 (Standard Care)
n=17 participants at risk
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.
|
Treatment Plan Option 2 (Precision Pharmacotherapy)
n=20 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • General recruitment began in February 2022 - December 2022 (approximately 10 months). Patients who were enrolled received an initial baseline intake survey followed by appointments one week (Week 1) and four weeks (Week 4) after beginning their medication. Patient data for adverse events were collected during the patient's entire enrollment (approximately 6 weeks).
|
5.0%
1/20 • General recruitment began in February 2022 - December 2022 (approximately 10 months). Patients who were enrolled received an initial baseline intake survey followed by appointments one week (Week 1) and four weeks (Week 4) after beginning their medication. Patient data for adverse events were collected during the patient's entire enrollment (approximately 6 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place