Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Smoking Cessation Clinical Trial

Official title:

Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511236
• Other study ID #: 20150356
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: October 23, 2019

Study information

• Verified date: June 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic

• Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm

• be over age 18

• speak/read English and/or Spanish

Exclusion Criteria:

• Contraindications for transdermal nicotine patch therapy (TNP)

• Cognitive or mental health impairment that inhibits group treatment

• Currently being treated for smoking cessation, alcoholism, or illicit drug use

• Unable to attend sessions

• Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)

• Does not self-identify as African American, Hispanic, or White (non-Hispanic)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Group Cognitive Behavioral Therapy
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.
• General Health Education
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).

Drug:
• Transdermal Nicotine Patch
Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida
United States	H Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	H. Lee Moffitt Cancer Center and Research Institute, James & Esther King Florida Biomedical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Reporting 7 Day Point Prevalence Abstinence	Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence	12-months
Primary	Change in Perceived Stress Scores	The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.	Baseline, 4 weeks
Primary	Change in Depressive Symptoms Scores	Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms.	Baseline, 4 weeks