Determinants of Smoking Cessation Among Latinos
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01008748
First received: October 2, 2009
Last updated: September 20, 2012
Last verified: September 2012
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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: | 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:
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 2014 (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. 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
|
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
Investigators
| Study Chair: | David Wetter, PhD, MS, BA | UT MD Anderson Cancer Center |
More Information
Additional Information:
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 20, 2012 |
| 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 June 18, 2013