CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 356 enrolled
Drug / intervention
Transdermal Nicotine Patch +2 moredrug
Likely dose
Transdermal Nicotine Patch 21 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02511236
NCT02511236Phase 4Completed

Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

University of Miami·interventional·Posted Jul 29, 2015·Updated Jun 24, 2021

In Brief

A Phase 4 clinical trial evaluating Group Cognitive Behavioral Therapy, General Health Education, and 1 other intervention for Smoking Cessation. Completed, enrolled 356 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 29, 2015
Enrollment StartAug 1, 2015
Primary CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.9 years ago

Interventions

Group Cognitive Behavioral Therapybehavioral

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 Educationbehavioral

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 Patchdrug

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.