Combined Treatment for Tobacco and Alcohol Use in Puerto Rico

NCT00570804 | Completed DMC

• 4 other identifiers: 2005-0791U54CA096300U54CA096297NCI-2012-02110
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
2. 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. 3.Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.

Conditions

Smoking

Keywords

Smoking Cessation; Puerto Rico Quitline; Motivational Relapse Prevention; Oral Cancer; Risk Reduction; Tobacco Use; Alcohol Use; MAPS; Motivation and Problem-Solving; Telephone Interview; Counseling

Outcome Measures

Primary Outcomes (1)

• Continuous outcome variables (including number of drinks per day, self-efficacy, etc.)

  2 Years

Study Arms (2)

MAPS+

OTHER

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; Behavioral: Telephone Assessments

MAPS

OTHER

MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation.

Behavioral: Telephone Counseling; Behavioral: Telephone Assessments

Interventions

Telephone Counseling BEHAVIORAL

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.

MAPS; MAPS+

Telephone Assessments BEHAVIORAL

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

Also known as: Survey, Questionnaire

MAPS; MAPS+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking; Smoking Cessation; Mouth Neoplasms; Risk Reduction Behavior; Tobacco Use; Alcohol Drinking

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Drinking Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lorna McNeill, MPH,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: December 1, 2007
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

US (1)