Trial Outcomes & Findings for Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence (NCT NCT03276780)
NCT ID: NCT03276780
Last Updated: 2024-05-08
Results Overview
Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
From baseline through 4 months
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
In Vivo
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
23
|
29
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
Reasons for withdrawal
| Measure |
In Vivo
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Moved out of state
|
1
|
1
|
|
Overall Study
Already enrolled in another smoking cessation study providing NRT
|
1
|
0
|
|
Overall Study
No show to appointments after baseline through Week 5
|
8
|
1
|
Baseline Characteristics
Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence
Baseline characteristics by cohort
| Measure |
In Vivo
n=41 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=39 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Total
n=80 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
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 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
|
41 participants
n=5 Participants
|
39 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Thinking of quitting smoking in the next month
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Thinking of quitting smoking within the next 6 months
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Tried NRT to help quit smoking before?
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Tried therapy to help quit smoking before?
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Tried self-help materials to help quit before?
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Tried hypnosis to help quit smoking before?
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Tried medication to help quit smoking before?
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Tried e-cigarettes to help quit smoking before?
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Are any medical problems worsened by smoking?
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Live with people who smoke?
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Quitting Smoking Behaviors at Baseline
Not thinking of quitting smoking
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cigarettes Per Day at Baseline
|
19.46 cigarettes per day
STANDARD_DEVIATION 11.05 • n=5 Participants
|
18.36 cigarettes per day
STANDARD_DEVIATION 9.26 • n=7 Participants
|
18.93 cigarettes per day
STANDARD_DEVIATION 10.17 • n=5 Participants
|
|
Carbon Monoxide (CO) Level at Baseline
|
18.56 parts per million (ppm) of CO
STANDARD_DEVIATION 11.28 • n=5 Participants
|
18.23 parts per million (ppm) of CO
STANDARD_DEVIATION 8.02 • n=7 Participants
|
18.40 parts per million (ppm) of CO
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Number of Years Smoked Reported at Baseline
|
24.73 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
28.92 years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
26.79 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Intensity of Nicotine Dependency at Baseline
|
6.49 scores on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
6.0 scores on a scale
STANDARD_DEVIATION 1.84 • n=7 Participants
|
6.26 scores on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
|
Smoking Urges at Baseline
|
46.07 units on a scale
STANDARD_DEVIATION 15.54 • n=5 Participants
|
44.36 units on a scale
STANDARD_DEVIATION 16.58 • n=7 Participants
|
45.24 units on a scale
STANDARD_DEVIATION 15.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline through 4 monthsFeasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.
Outcome measures
| Measure |
In Vivo
n=41 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=39 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Rate of Participant Retention
Participant retention rate
|
23 Participants
|
29 Participants
|
|
Rate of Participant Retention
Participant attrition rate
|
18 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 56 weeksThe acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study.
Outcome measures
| Measure |
In Vivo
n=327 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Rate of Recruitment
|
5.84 participants screened per week
|
—
|
PRIMARY outcome
Timeframe: 56 weeksThe acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study.
Outcome measures
| Measure |
In Vivo
n=80 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Rate of Enrollment
|
1.43 participants enrolled per week
|
—
|
PRIMARY outcome
Timeframe: 5 weeksTreatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.
Outcome measures
| Measure |
In Vivo
n=27 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=35 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Satisfaction
|
67.70 score on a scale
Standard Deviation 3.81
|
69.20 score on a scale
Standard Deviation 4.81
|
PRIMARY outcome
Timeframe: 13 weeksTreatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.
Outcome measures
| Measure |
In Vivo
n=23 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=31 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Satisfaction
|
65.21 score on a scale
Standard Deviation 10.67
|
66.39 score on a scale
Standard Deviation 5.91
|
PRIMARY outcome
Timeframe: 4 monthsTreatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.
Outcome measures
| Measure |
In Vivo
n=29 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=23 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Satisfaction
|
66.35 score on a scale
Standard Deviation 9.82
|
65.62 score on a scale
Standard Deviation 10.57
|
PRIMARY outcome
Timeframe: Assessed at baselineTreatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome.
Outcome measures
| Measure |
In Vivo
n=21 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=22 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Expectancies at Baseline
|
23.29 score on a scale
Standard Deviation 7.68
|
21.23 score on a scale
Standard Deviation 10.58
|
PRIMARY outcome
Timeframe: 5 weeksTreatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.
Outcome measures
| Measure |
In Vivo
n=27 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=35 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Credibility
|
1.43 score on a scale
Standard Deviation 3.67
|
0.84 score on a scale
Standard Deviation 5.05
|
PRIMARY outcome
Timeframe: 13 weeksTreatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.
Outcome measures
| Measure |
In Vivo
n=23 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=31 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Credibility
|
-0.74 score on a scale
Standard Deviation 5.12
|
0.08 score on a scale
Standard Deviation 3.78
|
PRIMARY outcome
Timeframe: 4 monthsTreatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.
Outcome measures
| Measure |
In Vivo
n=23 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=29 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Treatment Credibility
|
-0.26 score on scale
Standard Deviation 5.22
|
-1.64 score on scale
Standard Deviation 5.47
|
PRIMARY outcome
Timeframe: From baseline through 6 weeksMedication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
Outcome measures
| Measure |
In Vivo
n=26 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=34 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Number of Participants With Medication Adherence at Week 6
No patch doses missed
|
22 Participants
|
26 Participants
|
|
Number of Participants With Medication Adherence at Week 6
No NRT doses missed
|
23 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: From baseline through 9 weeksMedication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
Outcome measures
| Measure |
In Vivo
n=26 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=33 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Number of Participants With Medication Adherence at Week 9
No patch doses missed
|
23 Participants
|
24 Participants
|
|
Number of Participants With Medication Adherence at Week 9
No NRT doses missed
|
26 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: From baseline through 13 weeksMedication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
Outcome measures
| Measure |
In Vivo
n=21 Participants
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=30 Participants
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Number of Participants With Medication Adherence at Week 13
No patch doses missed
|
18 Participants
|
21 Participants
|
|
Number of Participants With Medication Adherence at Week 13
No NRT doses missed
|
17 Participants
|
22 Participants
|
Adverse Events
In Vivo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Standard of Care
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
In Vivo
n=41 participants at risk
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=39 participants at risk
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/41 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
Psychiatric disorders
Severe Depression
|
0.00%
0/41 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
General disorders
Undisclosed Virus
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
Other adverse events
| Measure |
In Vivo
n=41 participants at risk
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
Standard of Care
n=39 participants at risk
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
combination NRT: Both groups will receive combination NRT to help with smoking cessation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Burning
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Tingling
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Irritation
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
4.9%
2/41 • Number of events 2 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Drainage
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Ear and labyrinth disorders
Ear Pain
|
4.9%
2/41 • Number of events 2 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Excessive Sneezing
|
4.9%
2/41 • Number of events 2 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
General disorders
Nicotine Dosage Too Strong
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
General disorders
Vivid Dreams/Nightmares
|
9.8%
4/41 • Number of events 4 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Burning Mouth/Throat
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
2/41 • Number of events 2 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Excessive Coughing
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
General disorders
Headache
|
4.9%
2/41 • Number of events 2 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/41 • Baseline through 4 months
|
2.6%
1/39 • Number of events 1 • Baseline through 4 months
|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41 • Number of events 3 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41 • Number of events 4 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
General disorders
Jitteriness
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Blistering
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Eye disorders
Watering Eyes
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
General disorders
Increased Heart Rate
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
|
General disorders
Tooth Pain
|
2.4%
1/41 • Number of events 1 • Baseline through 4 months
|
0.00%
0/39 • Baseline through 4 months
|
Additional Information
Dr. Karen Cropsey
University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology
Phone: 205-975-4204
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place