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Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental | 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 |
|
| Nicotine Replacement Therapy Sampling | Active Comparator | 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. |
|
| Referral Only | Other | Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 30 days |
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Cigarettes Per Day | Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm | 30 days |
| Importance, Confidence, & Readiness Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc L Steinberg, Ph.D. | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Addiction Psychiatry | New Brunswick | New Jersey | 08901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Count of Participants | Participants | 30 days |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc L. Steinberg, Ph.D. | Rutgers Robert Wood Johnson Medical School | 732-235-4341 | marc.steinberg@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2019 | Sep 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2019 | Oct 25, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D000095488 | Nicotine Replacement Therapy |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Randomized clinical trial in which participants are randomized to one of three groups.
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The individual conducting the outcomes assessment is blind to study condition.
| Nicotine Replacement Therapy Sampling | Drug | 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 | Behavioral | Participants are provided with a written referral for tobacco dependence treatment. |
|
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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)
| 30 days |
| 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) | 30 days |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes Per day | Mean | Standard Deviation | cigarettes per day |
|
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. |
| OG002 | 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. |
|
|
|
| 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 | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Self-reported Cigarettes Per Day | Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm | Posted | Mean | Standard Deviation | cigarettes/day | 30 days |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
|
| Readiness to Quit (0-10) |
|
| ANOVA |
| .715 |
| Mean Difference (Final Values) |
| 0.338 |
| 2-Sided |
| Superiority |
| Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking. | ANOVA | .190 | Mean Difference (Final Values) | 1.712 | 2-Sided | Superiority |