Trial Outcomes & Findings for Tobacco and Socioeconomic Disadvantage (NCT NCT03620708)
NCT ID: NCT03620708
Last Updated: 2019-11-15
Results Overview
A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
30 days
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Motivational Interviewing
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Tobacco and Socioeconomic Disadvantage
Baseline characteristics by cohort
| Measure |
Motivational Interviewing
n=19 Participants
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
n=19 Participants
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
n=20 Participants
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
White / Latinx
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White / Non-Latinx
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black / Latinx
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black / Non-Latinx
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaskan Native and Latinx
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Don't Know / Refused
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaskan Native and Not Latinx
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Cigarettes Per day
|
15.47 cigarettes per day
STANDARD_DEVIATION 6.57 • n=5 Participants
|
11.84 cigarettes per day
STANDARD_DEVIATION 10.94 • n=7 Participants
|
13.45 cigarettes per day
STANDARD_DEVIATION 6.58 • n=5 Participants
|
13.59 cigarettes per day
STANDARD_DEVIATION 8.25 • n=4 Participants
|
|
Age, Continuous
|
46.32 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
50.53 years
STANDARD_DEVIATION 7.97 • n=7 Participants
|
45.65 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
47.47 years
STANDARD_DEVIATION 10.61 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender Woman
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Transgender Man
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysA self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."
Outcome measures
| Measure |
Motivational Interviewing
n=18 Participants
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
n=18 Participants
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
n=17 Participants
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'
|
5 Participants
|
10 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 30 daysSelf-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment
Outcome measures
| Measure |
Motivational Interviewing
n=18 Participants
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
n=18 Participants
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
n=17 Participants
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysSelf-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide \< 5ppm
Outcome measures
| Measure |
Motivational Interviewing
n=18 Participants
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
n=18 Participants
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
n=17 Participants
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Self-reported Cigarettes Per Day
|
13.0 cigarettes/day
Standard Deviation 7.1
|
7.6 cigarettes/day
Standard Deviation 6.3
|
10.3 cigarettes/day
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 30 daysMotivation and Self-efficacy for quitting smoking measured via Importance, Confidence, \& Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)
Outcome measures
| Measure |
Motivational Interviewing
n=18 Participants
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
n=18 Participants
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
n=17 Participants
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Importance, Confidence, & Readiness Questionnaire
Confidence in ability to quit (0-10)
|
4.8 score on a scale
Standard Deviation 2.8
|
5.5 score on a scale
Standard Deviation 3.2
|
6.5 score on a scale
Standard Deviation 2.8
|
|
Importance, Confidence, & Readiness Questionnaire
Importance of Quitting (0-10)
|
7.6 score on a scale
Standard Deviation 2.9
|
7.3 score on a scale
Standard Deviation 3.4
|
8.1 score on a scale
Standard Deviation 3.0
|
|
Importance, Confidence, & Readiness Questionnaire
Readiness to Quit (0-10)
|
3.8 score on a scale
Standard Deviation 3.1
|
5.1 score on a scale
Standard Deviation 3.2
|
5.6 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 30 days"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)
Outcome measures
| Measure |
Motivational Interviewing
n=18 Participants
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
Motivational Interviewing: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
|
Nicotine Replacement Therapy Sampling
n=18 Participants
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Nicotine Replacement Therapy Sampling: Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
|
Referral Only
n=17 Participants
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Referral Only: Participants are provided with a written referral for tobacco dependence treatment.
|
|---|---|---|---|
|
Readiness to Quit Ladder
|
5.7 score on a scale
Standard Deviation 1.3
|
6.6 score on a scale
Standard Deviation 2.1
|
6.4 score on a scale
Standard Deviation 2.0
|
Adverse Events
Motivational Interviewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotine Replacement Therapy Sampling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Referral Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marc L. Steinberg, Ph.D.
Rutgers Robert Wood Johnson Medical School
Phone: 732-235-4341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place