Combined Treatment for Tobacco and Alcohol Use in Puerto Rico

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00570804
First received: December 7, 2007
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

Objectives:

  1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
  2. 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.
  3. 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:


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 2015 (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

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Current (daily) smoker requesting help for smoking cessation
  2. 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.
  3. Age 18 or above
  4. Motivated to quit smoking in the next 30 days
  5. Viable (working) telephone number and home address
  6. No other household member enrolled in this protocol
  7. Residing in Puerto Rico
  8. Must score less than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)

Exclusion Criteria:

  1. Currently incarcerated or in jail
  2. Currently pregnant
  3. Score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT) measure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: David Wetter, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
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 20, 2013
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
Drinking Behavior
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 26, 2014