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End Nicotine Dependence Clinic

Primary Purpose

Smoking Cessation

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Group Counseling

Individual Counseling

Phone Counseling

Video Counseling

Texting support

Nicotine Replacement Therapy

About this trial

This is an interventional supportive care trial for Smoking Cessation focused on measuring Nicotine Dependence, applied behavioral research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Case Western Reserve University, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group Counseling

Individual Counseling

Telephone Counseling

Video Counseling

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Rate of 7-day smoking abstinence across intervention

Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking)

Rate of 28-day smoking abstinence across intervention

Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking)

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.]

Sessions completed

Average count of sessions each participant completed (1-8)

Study Retention

Nicotine Replacement Therapy (NRT) Completed

Average count of doses of NRT taken by participants

Full Information

NCT ID

NCT03290430

First Posted

September 19, 2017

Last Updated

April 10, 2020

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03290430

Brief Title

End Nicotine Dependence Clinic

Official Title

End Nicotine Dependence (END) Clinic

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 9, 2018 (Actual)

Primary Completion Date

December 6, 2019 (Actual)

Study Completion Date

January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation

Keywords

Nicotine Dependence, applied behavioral research

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group Counseling

Arm Type

Experimental

Arm Description

Arm Title

Individual Counseling

Arm Type

Experimental

Arm Description

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.

Arm Title

Telephone Counseling

Arm Type

Experimental

Arm Description

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.

Arm Title

Video Counseling

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Group Counseling

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Individual Counseling

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Phone Counseling

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Video Counseling

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Texting support

Intervention Description

Texts with smoking cessation support throughout the program

Intervention Type

Drug

Intervention Name(s)

Nicotine Replacement Therapy

Other Intervention Name(s)

Nicotine Patch, Nicotine Gum, NRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of 24 hour smoking abstinence across intervention

Description

Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking)

Time Frame

Up to 24 hours after session 1

Secondary Outcome Measure Information:

Title

Rate of 7-day smoking abstinence across intervention

Description

Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking)

Time Frame

Up to 7 days after session 1

Title

Rate of 28-day smoking abstinence across intervention

Description

Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking)

Time Frame

Up to 28 days after session 1

Title

Average intervention rating

Description

Time Frame

Up to 4 weeks after session 1

Title

Sessions completed

Description

Average count of sessions each participant completed (1-8)

Time Frame

Up to 4 weeks after session 1

Title

Study Retention

Time Frame

Up to 4 weeks after session 1

Title

Nicotine Replacement Therapy (NRT) Completed

Description

Average count of doses of NRT taken by participants

Time Frame

Up to 4 weeks after session 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica Webb Hooper, PhD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Case Western Reserve University, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

End Nicotine Dependence Clinic

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