Combined Treatment for Tobacco and Alcohol Use in Puerto Rico - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00570804

Purpose

Objectives:

Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy, decreased temptations/craving, decreased stress and negative affect) and the role of those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.

Condition	Intervention
Smoking	Behavioral: Telephone Counseling Behavioral: Telephone Assessments

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Cancer Oral Cancer Quitting Smoking Smoking

U.S. FDA Resources

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

Primary Outcome Measures:

Continuous outcome variables (including number of drinks per day, self-efficacy, etc.) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	370
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MAPS+ MAPS+ (Motivation and Problem-Solving Plus): Counseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use.	Behavioral: Telephone Counseling 7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete. Behavioral: Telephone Assessments 4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete. Other Names: Survey Questionnaire
MAPS MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation.	Behavioral: Telephone Counseling 7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete. Behavioral: Telephone Assessments 4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete. Other Names: Survey Questionnaire

Arms

Assigned Interventions

MAPS+

MAPS+ (Motivation and Problem-Solving Plus):

Counseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use.

Behavioral: Telephone Counseling

7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.

Behavioral: Telephone Assessments

4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.

Other Names:

Survey
Questionnaire

MAPS

MAPS (Motivation and Problem-Solving):

Counseling treatment approach with a focus on smoking cessation.

Behavioral: Telephone Counseling

7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.

Behavioral: Telephone Assessments

4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.

Other Names:

Survey
Questionnaire

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Current (daily) smoker requesting help for smoking cessation
Exhibit at least one of the following criteria for at-risk drinking: a) an average of =/> 2 alcoholic beverages/day during the past 30 days for men or =/>1 drink/day for women, OR b) two or more occasions of consuming /=> 5 alcoholic beverages during the past 30 days for men or =/>4 drinks for women, OR c) in the past 30 days, driving after consuming =/>3 drinks.
Age 18 or above
Motivated to quit smoking in the next 30 days
Viable (working) telephone number and home address
No other household member enrolled in this protocol
Residing in Puerto Rico
Must score less than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)

Exclusion Criteria:

Currently incarcerated or in jail
Currently pregnant
Score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT) measure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570804

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David Wetter, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00570804 History of Changes
Other Study ID Numbers:	2005-0791
Study First Received:	December 7, 2007
Last Updated:	November 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Smoking Cessation
Puerto Rico Quitline
Motivational Relapse Prevention
Oral Cancer
Risk Reduction
Tobacco Use

Alcohol Use
MAPS
Motivation and Problem-Solving
Telephone Interview
Counseling

Additional relevant MeSH terms:

Alcohol Drinking
Mouth Neoplasms
Smoking
Drinking Behavior
Head and Neck Neoplasms

Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Habits

ClinicalTrials.gov processed this record on May 22, 2012