End Nicotine Dependence Clinic

Study Overview
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Brief Summary
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The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.

Detailed Description
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Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the opportunity to receive a CBT-based tobacco intervention delivered several possible formats (face-to-face, telephone, video-counseling) based on availability and participant preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse prevention strategies, and discuss barriers to cessation, previous quit attempts, risky situations, and benefits observed after quitting. Participants may also complete exercises designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine replacement therapy and text-messaging support. Objective 2: To examine the rates of smoking abstinence across intervention formats. Investigators will attempt to follow-up with participants for a 6-months after program completion. Investigators will assess point prevalence abstinence for each intervention delivery method. Objective 3: To assess individual difference variables that influence outcomes. Investigators will examine individual-difference predictors of outcomes, such as readiness to quit, social support, distress, and environmental factors.

Official Title
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End Nicotine Dependence (END) Clinic

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Group Counseling
* Behavioral: Individual Counseling
* Behavioral: Phone Counseling
* Behavioral: Video Counseling
* Behavioral: Texting support
* Drug: Nicotine Replacement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a breath carbon monoxide (CO) reading of ≥ 8 ppm) Able to speak and read English Able to engage using at least one of the intervention formats. Exclusion Criteria: Enrollment in another cessation program Do not speak and read English Do not have access to at least one intervention format Have contraindications for NRT Do not have contact information (e.g., address, telephone number) Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse) They endorse active addiction to another substance (e.g., illicit drugs or alcohol). People who self-report having a severe mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Counseling<br>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 1-2 hours. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy. | Behavioral: Group Counseling<br>* 8 sessions over 4 weeks. Lasting 1-2 hours each<br>Behavioral: Texting support<br>* Texts with smoking cessation support throughout the program<br>Drug: Nicotine Replacement Therapy<br>* Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy<br>* Other names: NRT;|
| Experimental: Individual Counseling<br>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 30-45 minutes. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy. | Behavioral: Individual Counseling<br>* 8 in person sessions over 4 weeks. Lasting 30-45 minutes each<br>Behavioral: Texting support<br>* Texts with smoking cessation support throughout the program<br>Drug: Nicotine Replacement Therapy<br>* Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy<br>* Other names: NRT;|
| Experimental: Telephone Counseling<br>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 phone calls over 4 week, each lasting between 30-45 minutes. During these phone calls, participants will learn about how to quit smoking by changing habits. Sessions may be audio taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy. | Behavioral: Phone Counseling<br>* 8 phone sessions over 4 weeks. Lasting 30-45 minutes each<br>Behavioral: Texting support<br>* Texts with smoking cessation support throughout the program<br>Drug: Nicotine Replacement Therapy<br>* Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy<br>* Other names: NRT;|
| Experimental: Video Counseling<br>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 video calls over 4 week, each lasting between 30-45 minutes. During these video calls, participants will learn about how to quit smoking by changing habits. Sessions may be recorded. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy. | Behavioral: Video Counseling<br>* 8 video call sessions over 4 weeks. Lasting 30-45 minutes each<br>Behavioral: Texting support<br>* Texts with smoking cessation support throughout the program<br>Drug: Nicotine Replacement Therapy<br>* Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy<br>* Other names: NRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of 24 hour smoking abstinence across intervention | Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking) | Up to 24 hours after session 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of 7-day smoking abstinence across intervention | Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking) | Up to 7 days after session 1 | 
| Rate of 28-day smoking abstinence across intervention | Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking) | Up to 28 days after session 1 | 
| Average intervention rating | Scaled survey will be used to assess the quality and the content of the intervention [i.e., the extent to which the content was informative, encouraging, attention capturing, credible, applicable to their lives, and comprehensible.] | Up to 4 weeks after session 1 | 
| Sessions completed | Average count of sessions each participant completed (1-8) | Up to 4 weeks after session 1 | 
| Study Retention |  | Up to 4 weeks after session 1 | 
| Nicotine Replacement Therapy (NRT) Completed | Average count of doses of NRT taken by participants | Up to 4 weeks after session 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Dependence, applied behavioral research