End Nicotine Dependence (END) Clinic
| Registry | NCT03290430 |
|---|---|
| Status | Completed |
| Phase | Early Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, supportive care |
| Enrollment | 56 (Actual) |
| Sponsor | Case Comprehensive Cancer Center (Other) |
| Conditions | Smoking Cessation |
| Interventions | Group Counseling, Individual Counseling, Phone Counseling, Video Counseling, Texting support, Nicotine Replacement Therapy (Behavioral, drug) |
| Dates | start 2018-01-09, primary completion 2019-12-06, completion 2020-01-06, first posted 2017-09-21, last updated 2020-04-14 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Smoking Cessation All trials of Group Counseling All trials of Individual Counseling
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group Counseling | Experimental | Behavioral: Group Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy | 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. |
| Individual Counseling | Experimental | Behavioral: Individual Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy | 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. |
| Telephone Counseling | Experimental | Behavioral: Phone Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy | 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. |
| Video Counseling | Experimental | Behavioral: Video Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy | 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Case Western Reserve University, Case Comprehensive Cancer Center | Cleveland, Ohio | United States |