End Nicotine Dependence Clinic

NCT03290430 | Completed Early Phase 1 FDA Drug

• 1 other identifier: CASE3Z17
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Nicotine Dependence; applied behavioral research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of 7-day smoking abstinence across intervention

  Up to 7 days after session 1

• Rate of 28-day smoking abstinence across intervention

  Up to 28 days after session 1

• Average intervention rating

  Up to 4 weeks after session 1

• Sessions completed

  Up to 4 weeks after session 1

• Study Retention

  Up to 4 weeks after session 1

Study Arms (4)

Group Counseling

EXPERIMENTAL

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; Behavioral: Texting support; Drug: Nicotine Replacement Therapy

Individual Counseling

EXPERIMENTAL

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; Behavioral: Texting support; Drug: Nicotine Replacement Therapy

Telephone Counseling

EXPERIMENTAL

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; Behavioral: Texting support; Drug: Nicotine Replacement Therapy

Video Counseling

EXPERIMENTAL

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; Behavioral: Texting support; Drug: Nicotine Replacement Therapy

Interventions

Group Counseling BEHAVIORAL

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

Group Counseling

Individual Counseling BEHAVIORAL

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

Individual Counseling

Phone Counseling BEHAVIORAL

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

Telephone Counseling

Video Counseling BEHAVIORAL

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

Video Counseling

Texting support BEHAVIORAL

Texts with smoking cessation support throughout the program

Group Counseling; Individual Counseling; Telephone Counseling; Video Counseling

Nicotine Replacement Therapy DRUG

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

Also known as: Nicotine Patch, Nicotine Gum, NRT

Group Counseling; Individual Counseling; Telephone Counseling; Video Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Monica Webb Hooper, PhD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: January 9, 2018
• Primary Completion: December 6, 2019
• Study Completion: January 6, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

US (1)