Determinants of Smoking Cessation Among Latinos - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	National Center on Minority Health and Health Disparities (NCMHD) Department of Health and Human Services National Institutes of Health (NIH)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01008748

Purpose

The goal of this study is to learn how neighborhood and individual factors affect the ability to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit smoking.

Condition	Intervention
Smoking Cessation	Drug: Nicotine Replacement Therapy (NRT) Behavioral: Questionnaire Behavioral: Counseling Behavioral: Self-Help Materials

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Determinants of Smoking Cessation Among Latinos

Resource links provided by NLM:

MedlinePlus related topics: Cancer Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Abstinence Rate [ Time Frame: Tracked from 1 week prior to quit date through 26 weeks post-quit date; assessed for 4 contiguous weeks (1 week pre-cessation through 3 weeks postcessation) using state-of-the-science ecological momentary assessment (EMA) procedures. ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	September 2009
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Smoking Cessation Treatment Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish	Drug: Nicotine Replacement Therapy (NRT) NRT for participants who smoke >10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits. Other Name: Nicotine Patch Therapy Behavioral: Questionnaire Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time. Other Name: Survey Behavioral: Counseling Each counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish. Behavioral: Self-Help Materials Spanish-language self-help materials currently used by the NCI's Cancer Information Service. Other Name: pamphlets

Arms

Assigned Interventions

Experimental: Smoking Cessation Treatment

Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish

Drug: Nicotine Replacement Therapy (NRT)

NRT for participants who smoke >10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits.

Other Name: Nicotine Patch Therapy

Behavioral: Questionnaire

Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.

Other Name: Survey

Behavioral: Counseling

Each counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish.

Behavioral: Self-Help Materials

Spanish-language self-help materials currently used by the NCI's Cancer Information Service.

Other Name: pamphlets

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Current daily smoker who average >/= 5 cigarettes/day for the last year
Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community
Age 18 to 65 years
Motivated to quit smoking in the next 30 days
Viable (working) telephone number and home address
Prefers to speak in Spanish
Register "8" or more on a carbon monoxide breath test

Exclusion Criteria:

Contraindication for nicotine patch use
Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
Pregnancy or lactation
Currently enrolled in a smoking cessation program
Participation in a smoking cessation program or study during the past 90 days
Another household member is enrolled in this protocol
Active substance abuse problem

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008748

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Center on Minority Health and Health Disparities (NCMHD)

Department of Health and Human Services

National Institutes of Health (NIH)

Investigators

Study Chair:

David Wetter, PhD, MS, BA

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01008748 History of Changes
Other Study ID Numbers:	2007-0442
Study First Received:	October 2, 2009
Last Updated:	September 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Smoking
Latinos
Mexican American
Spanish-speaking smokers
Ecological momentary assessment

Nicotine patch
Smoking cessation counseling
Questionnaire
EMA

Additional relevant MeSH terms:

Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012