Tobacco and Socioeconomic Disadvantage
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|ClinicalTrials.gov Identifier: NCT03620708|
Recruitment Status : Completed
First Posted : August 8, 2018
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Smoking||Behavioral: Motivational Interviewing Drug: Nicotine Replacement Therapy Sampling Behavioral: Referral Only||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical trial in which participants are randomized to one of three groups.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The individual conducting the outcomes assessment is blind to study condition.|
|Official Title:||Addressing Tobacco Use Among Those At Socioeconomic Disadvantage|
|Actual Study Start Date :||May 30, 2018|
|Actual Primary Completion Date :||October 1, 2018|
|Actual Study Completion Date :||October 1, 2018|
Experimental: 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
Behavioral: 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.
Active Comparator: 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.
Drug: 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.
Other Name: Nicotine Replacement Therapy
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
Behavioral: Referral Only
Participants are provided with a written referral for tobacco dependence treatment.
Other Name: Referral
- Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' [ Time Frame: 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' [ Time Frame: 30 days ]Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment
- Self-reported Cigarettes Per Day [ Time Frame: 30 days ]Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm
- Importance, Confidence, & Readiness Questionnaire [ Time Frame: 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 [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620708
|United States, New Jersey|
|Division of Addiction Psychiatry|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Marc L Steinberg, Ph.D.||Rutgers Robert Wood Johnson Medical School|