Tobacco Smoking
Conditions
Keywords
tobacco, smoking, cigarette
Brief summary
Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
Detailed description
The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.
Interventions
BEHAVIORALMotivational 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.
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.
BEHAVIORALReferral Only
Participants are provided with a written referral for tobacco dependence treatment.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The individual conducting the outcomes assessment is blind to study condition.
Intervention model description
Randomized clinical trial in which participants are randomized to one of three groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be between the age of 19 and 65 * Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading \>5) * Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, Elijah's Promise) * Participants must be able to speak and read English.
Exclusion criteria
* Participants may not be taking FDA approved smoking cessation or anti-psychotic medications * Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days) * Participants may not report pending legal issues with potential to result in incarceration. * Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' | 30 days | A self-described serious attempt to quit smoking cigarettes since the initial study appointment, measured by the Quitting Preparation and Actions Questionnaire. |
| Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' | 30 days | Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Cigarettes Per Day | 30 days | Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide \< 5ppm |
| Importance, Confidence, & Readiness Questionnaire | 30 days | Motivation 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) |
| Readiness to Quit Ladder | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 19 |
| 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. | 20 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Motivational Interviewing | Nicotine Replacement Therapy Sampling | Referral Only | Total |
|---|---|---|---|---|
| Age, Continuous | 46.32 years STANDARD_DEVIATION 12.37 | 50.53 years STANDARD_DEVIATION 7.97 | 45.65 years STANDARD_DEVIATION 10.87 | 47.47 years STANDARD_DEVIATION 10.61 |
| Cigarettes Per day | 15.47 cigarettes per day STANDARD_DEVIATION 6.57 | 11.84 cigarettes per day STANDARD_DEVIATION 10.94 | 13.45 cigarettes per day STANDARD_DEVIATION 6.58 | 13.59 cigarettes per day STANDARD_DEVIATION 8.25 |
| Race/Ethnicity, Customized American Indian / Alaskan Native and Latinx | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian / Alaskan Native and Not Latinx | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black / Latinx | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black / Non-Latinx | 7 Participants | 8 Participants | 7 Participants | 22 Participants |
| Race/Ethnicity, Customized Don't Know / Refused | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White / Latinx | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized White / Non-Latinx | 10 Participants | 4 Participants | 8 Participants | 22 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 20 participants | 58 participants |
| Sex/Gender, Customized Female | 7 Participants | 4 Participants | 6 Participants | 17 Participants |
| Sex/Gender, Customized Male | 11 Participants | 14 Participants | 14 Participants | 39 Participants |
| Sex/Gender, Customized Transgender Man | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender Woman | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 20 |
Outcome results
Primary
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'
A self-described serious attempt to quit smoking cigarettes since the initial study appointment, measured by the Quitting Preparation and Actions Questionnaire.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interviewing | Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' | 5 Participants |
| Nicotine Replacement Therapy Sampling | Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' | 10 Participants |
| Referral Only | Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' | 6 Participants |
p-value: <0.05Chi-squared
Primary
Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'
Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interviewing | Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' | 0 Participants |
| Nicotine Replacement Therapy Sampling | Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' | 1 Participants |
| Referral Only | Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' | 3 Participants |
p-value: 0.113Chi-squared
Secondary
Importance, Confidence, & Readiness Questionnaire
Motivation 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)
Time frame: 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing | Importance, Confidence, & Readiness Questionnaire | Importance of Quitting (0-10) | 7.6 score on a scale | Standard Deviation 2.9 |
| Motivational Interviewing | Importance, Confidence, & Readiness Questionnaire | Confidence in ability to quit (0-10) | 4.8 score on a scale | Standard Deviation 2.8 |
| Motivational Interviewing | Importance, Confidence, & Readiness Questionnaire | Readiness to Quit (0-10) | 3.8 score on a scale | Standard Deviation 3.1 |
| Nicotine Replacement Therapy Sampling | Importance, Confidence, & Readiness Questionnaire | Importance of Quitting (0-10) | 7.3 score on a scale | Standard Deviation 3.4 |
| Nicotine Replacement Therapy Sampling | Importance, Confidence, & Readiness Questionnaire | Confidence in ability to quit (0-10) | 5.5 score on a scale | Standard Deviation 3.2 |
| Nicotine Replacement Therapy Sampling | Importance, Confidence, & Readiness Questionnaire | Readiness to Quit (0-10) | 5.1 score on a scale | Standard Deviation 3.2 |
| Referral Only | Importance, Confidence, & Readiness Questionnaire | Confidence in ability to quit (0-10) | 6.5 score on a scale | Standard Deviation 2.8 |
| Referral Only | Importance, Confidence, & Readiness Questionnaire | Readiness to Quit (0-10) | 5.6 score on a scale | Standard Deviation 3 |
| Referral Only | Importance, Confidence, & Readiness Questionnaire | Importance of Quitting (0-10) | 8.1 score on a scale | Standard Deviation 3 |
Comparison: Examination of differences between groups at follow-up on a measure of confidence in ability to quit.p-value: 0.227ANOVA
Comparison: Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.p-value: 0.715ANOVA
Comparison: Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.p-value: 0.19ANOVA
Secondary
Readiness to Quit Ladder
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)
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing | Readiness to Quit Ladder | 5.7 score on a scale | Standard Deviation 1.3 |
| Nicotine Replacement Therapy Sampling | Readiness to Quit Ladder | 6.6 score on a scale | Standard Deviation 2.1 |
| Referral Only | Readiness to Quit Ladder | 6.4 score on a scale | Standard Deviation 2 |
p-value: 0.188ANOVA
Secondary
Self-reported Cigarettes Per Day
Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide \< 5ppm
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing | Self-reported Cigarettes Per Day | 13.0 cigarettes/day | Standard Deviation 7.1 |
| Nicotine Replacement Therapy Sampling | Self-reported Cigarettes Per Day | 7.6 cigarettes/day | Standard Deviation 6.3 |
| Referral Only | Self-reported Cigarettes Per Day | 10.3 cigarettes/day | Standard Deviation 6.9 |
p-value: 0.032ANOVA