Clinical trial NCT03290430: End Nicotine Dependence Clinic
Official title: End Nicotine Dependence (END) Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Keywords: Nicotine Dependence
applied behavioral research
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of 24 hour smoking abstinence across intervention
timeFrame: Up to 24 hours after session 1
Secondary outcomes:
measure: Rate of 7-day smoking abstinence across intervention
timeFrame: Up to 7 days after session 1
measure: Rate of 28-day smoking abstinence across intervention
timeFrame: Up to 28 days after session 1
measure: Average intervention rating
timeFrame: Up to 4 weeks after session 1
measure: Sessions completed
timeFrame: Up to 4 weeks after session 1
measure: Study Retention
timeFrame: Up to 4 weeks after session 1
measure: Nicotine Replacement Therapy (NRT) Completed
timeFrame: Up to 4 weeks after session 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Monica Webb Hooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: