End Nicotine Dependence Clinic

Smoking Cessation Clinical Trial

Official title:

End Nicotine Dependence (END) Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290430
• Other study ID #: CASE3Z17
• Status: Completed
• Phase: Early Phase 1
• Start date: January 9, 2018
• Est. completion date: January 6, 2020

Study information

• Verified date: April 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 6, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• Group Counseling
8 sessions over 4 weeks. Lasting 1-2 hours each
• Individual Counseling
8 in person sessions over 4 weeks. Lasting 30-45 minutes each
• Phone Counseling
8 phone sessions over 4 weeks. Lasting 30-45 minutes each
• Video Counseling
8 video call sessions over 4 weeks. Lasting 30-45 minutes each
• 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

Locations

Country	Name	City	State
United States	Case Western Reserve University, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sessions completed	Average count of sessions each participant completed (1-8)	Up to 4 weeks after session 1
Secondary	Study Retention		Up to 4 weeks after session 1
Secondary	Nicotine Replacement Therapy (NRT) Completed	Average count of doses of NRT taken by participants	Up to 4 weeks after session 1