Skip to main content
OpenTrials
Completed

NCT Number: NCT02511236

Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami, Coral Gables, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Group Cognitive Behavioral Therapy

Behavioral

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

Behavioral

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).

Transdermal Nicotine Patch

Drug

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.

Other names: Nicotine Patch

Primary outcomes

  1. The Number of Participants Reporting 7 Day Point Prevalence Abstinence

    Time frame: 12-months

    Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence

  2. Change in Perceived Stress Scores

    Time frame: Baseline, 4 weeks

    The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.

  3. Change in Depressive Symptoms Scores

    Time frame: Baseline, 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • James and Esther King Biomedical Research Program

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 29, 2015
Registry last updated
Jun 24, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.