End Nicotine Dependence Clinic

NCT ID: NCT03290430

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2020-01-06

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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group Counseling

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.

Group Type EXPERIMENTAL

Group Counseling

Intervention Type BEHAVIORAL

8 sessions over 4 weeks. Lasting 1-2 hours each

Texting support

Intervention Type BEHAVIORAL

Texts with smoking cessation support throughout the program

Nicotine Replacement Therapy

Intervention Type DRUG

Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy

Individual Counseling

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.

Group Type EXPERIMENTAL

Individual Counseling

Intervention Type BEHAVIORAL

8 in person sessions over 4 weeks. Lasting 30-45 minutes each

Texting support

Intervention Type BEHAVIORAL

Texts with smoking cessation support throughout the program

Nicotine Replacement Therapy

Intervention Type DRUG

Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy

Telephone Counseling

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.

Group Type EXPERIMENTAL

Phone Counseling

Intervention Type BEHAVIORAL

8 phone sessions over 4 weeks. Lasting 30-45 minutes each

Texting support

Intervention Type BEHAVIORAL

Texts with smoking cessation support throughout the program

Nicotine Replacement Therapy

Intervention Type DRUG

Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy

Video Counseling

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.

Group Type EXPERIMENTAL

Video Counseling

Intervention Type BEHAVIORAL

8 video call sessions over 4 weeks. Lasting 30-45 minutes each

Texting support

Intervention Type BEHAVIORAL

Texts with smoking cessation support throughout the program

Nicotine Replacement Therapy

Intervention Type DRUG

Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy

Interventions

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Group Counseling

8 sessions over 4 weeks. Lasting 1-2 hours each

Intervention Type BEHAVIORAL

Individual Counseling

8 in person sessions over 4 weeks. Lasting 30-45 minutes each

Intervention Type BEHAVIORAL

Phone Counseling

8 phone sessions over 4 weeks. Lasting 30-45 minutes each

Intervention Type BEHAVIORAL

Video Counseling

8 video call sessions over 4 weeks. Lasting 30-45 minutes each

Intervention Type BEHAVIORAL

Texting support

Texts with smoking cessation support throughout the program

Intervention Type BEHAVIORAL

Nicotine Replacement Therapy

Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy

Intervention Type DRUG

Other Intervention Names

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Nicotine Patch Nicotine Gum NRT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monica Webb Hooper, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

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Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE3Z17

Identifier Type: -

Identifier Source: org_study_id

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