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Completed

NCT Number: NCT03290430

End Nicotine Dependence 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.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group counseling

Behavioral

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

Individual counseling

Behavioral

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

Phone counseling

Behavioral

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

Video Counseling

Behavioral

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

Texting support

Behavioral

Texts with smoking cessation support throughout the program

Nicotine Replacement Therapy

Drug

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

Other names: Nicotine Patch, Nicotine Gum, NRT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

End Nicotine Dependence (END) Clinic

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 21, 2017
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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