End Nicotine Dependence Clinic

End Nicotine Dependence (END) Clinic

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Group Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy; Behavioral: Individual Counseling; Behavioral: Phone Counseling; Behavioral: Video Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Group Counseling; 8 sessions over 4 weeks. Lasting 1-2 hours each; Behavioral: Texting support; Texts with smoking cessation support throughout the program; Drug: Nicotine Replacement Therapy; Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy; Other Names: NRT; Nicotine Gum; Nicotine Patch
Experimental: 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.	Behavioral: Texting support; Texts with smoking cessation support throughout the program; Drug: Nicotine Replacement Therapy; Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy; Other Names: NRT; Nicotine Gum; Nicotine Patch; Behavioral: Individual Counseling; 8 in person sessions over 4 weeks. Lasting 30-45 minutes each
Experimental: 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.	Behavioral: Texting support; Texts with smoking cessation support throughout the program; Drug: Nicotine Replacement Therapy; Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy; Other Names: NRT; Nicotine Gum; Nicotine Patch; Behavioral: Phone Counseling; 8 phone sessions over 4 weeks. Lasting 30-45 minutes each
Experimental: 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.	Behavioral: Texting support; Texts with smoking cessation support throughout the program; Drug: Nicotine Replacement Therapy; Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy; Other Names: NRT; Nicotine Gum; Nicotine Patch; Behavioral: Video Counseling; 8 video call sessions over 4 weeks. Lasting 30-45 minutes each

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Monica Webb Hooper, PhD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Nicotine Dependence; applied behavioral research
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: CASE3Z17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No