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End Nicotine Dependence Clinic

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ClinicalTrials.gov Identifier: NCT03290430
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Group Counseling Behavioral: Individual Counseling Behavioral: Phone Counseling Behavioral: Video Counseling Behavioral: Texting support Drug: Nicotine Replacement Therapy Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: End Nicotine Dependence (END) Clinic
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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:
  • Nicotine Patch
  • Nicotine Gum
  • NRT

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: Individual Counseling
8 in person sessions over 4 weeks. Lasting 30-45 minutes 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:
  • Nicotine Patch
  • Nicotine Gum
  • NRT

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: Phone Counseling
8 phone sessions over 4 weeks. Lasting 30-45 minutes 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:
  • Nicotine Patch
  • Nicotine Gum
  • NRT

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: Video Counseling
8 video call sessions over 4 weeks. Lasting 30-45 minutes 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:
  • Nicotine Patch
  • Nicotine Gum
  • NRT




Primary Outcome Measures :
  1. Rate of 24 hour smoking abstinence across intervention [ Time Frame: Up to 24 hours after session 1 ]
    Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking)


Secondary Outcome Measures :
  1. Rate of 7-day smoking abstinence across intervention [ Time Frame: Up to 7 days after session 1 ]
    Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking)

  2. Rate of 28-day smoking abstinence across intervention [ Time Frame: Up to 28 days after session 1 ]
    Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking)

  3. Average intervention rating [ Time Frame: Up to 4 weeks after session 1 ]
    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.]

  4. Sessions completed [ Time Frame: Up to 4 weeks after session 1 ]
    Average count of sessions each participant completed (1-8)

  5. Study Retention [ Time Frame: Up to 4 weeks after session 1 ]
  6. Nicotine Replacement Therapy (NRT) Completed [ Time Frame: Up to 4 weeks after session 1 ]
    Average count of doses of NRT taken by participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290430


Contacts
Contact: Monica Webb Hooper, PhD 216-368-6895 mwh54@case.edu

Locations
United States, Ohio
Case Western Reserve University, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Monica Webb Hooper, PhD    216-368-6895    mwh54@case.edu   
Principal Investigator: Monica Webb Hooper, PhD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Monica Webb Hooper, PhD Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03290430     History of Changes
Other Study ID Numbers: CASE3Z17
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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

Keywords provided by Case Comprehensive Cancer Center:
Nicotine Dependence
applied behavioral research

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action