NCT03290430

End Nicotine Dependence Clinic

End Nicotine Dependence (END) Clinic

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Group Counseling	8 sessions over 4 weeks. Lasting 1-2 hours each
BEHAVIORAL	Individual Counseling	8 in person sessions over 4 weeks. Lasting 30-45 minutes each
BEHAVIORAL	Phone Counseling	8 phone sessions over 4 weeks. Lasting 30-45 minutes each
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

Timeline

• Start date: 2018-01-09
• Primary completion: 2019-12-06
• Completion: 2020-01-06
• First posted: 2017-09-21
• Last updated: 2020-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study