Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

June 1, 2021 updated by: David Lee, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33124
        • University of Miami
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Cognitive Behavioral Therapy
Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].
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.
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.
Other Names:
  • Nicotine Patch
Active Comparator: General Health Education
Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].
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.
Other Names:
  • Nicotine Patch
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-months
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.
Baseline, 4 weeks
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.
Baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

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

Investigators

  • Principal Investigator: David Lee, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 23, 2019

Study Completion (Actual)

October 23, 2019

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Group Cognitive Behavioral Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe