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Determinants of Smoking Cessation Among Latinos

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008748
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Department of Health and Human Services
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine Replacement Therapy (NRT) Behavioral: Questionnaire Behavioral: Counseling Behavioral: Self-Help Materials Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determinants of Smoking Cessation Among Latinos
Study Start Date : September 2009
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoking Cessation Treatment
Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
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




Primary Outcome Measures :
  1. Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day) [ Time Frame: Week 3 post quit day ]
    Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.

  2. 24-Hour Smoking Abstinence (Week 26 Post Quit Day) [ Time Frame: Week 26 post quit day ]
    Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.

  3. 7-Day Smoking Abstinence (Week 3 Post Quit Day) [ Time Frame: Week 3 post quit day ]
    Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

  4. 7-Day Smoking Abstinence (Week 26 Post Quit Day) [ Time Frame: Week 26 post quit day ]
    Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

  5. 30-Day Smoking Abstinence (Week 26 Post Quit Day) [ Time Frame: Week 26 post quit day ]
    Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.

  6. 7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat [ Time Frame: Week 3 post quit day ]
    Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

  7. 7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat [ Time Frame: Week 26 post quit day ]
    Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

  8. 7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence [ Time Frame: Week 3 post quit day ]
    Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach

  9. 7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence [ Time Frame: Week 26 post quit day ]
    Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008748


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute on Minority Health and Health Disparities (NIMHD)
Department of Health and Human Services
National Institutes of Health (NIH)
Investigators
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Principal Investigator: David Wetter, PhD, MS, BA M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01008748    
Other Study ID Numbers: 2007-0442
2P60MD000503-05 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2009    Key Record Dates
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020
Last Verified: March 2020
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:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action