Comparing Population Cessation Services

September 16, 2013 updated by: James O. Prochaska, University of Rhode Island

Comparing Population Cessation Services With Emphasis on Unmotivated Smokers

If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement Therapy and Transtheoretical tailored interventions produces an increasing treatment trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and population cessation generally. These recruitment and intervention strategies require limited resources from health care providers and could be readily disseminable to other health care systems for application with populations of smokers, especially unmotivated smokers who have been understudied and underserved.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This proposal addresses major gaps in research for nicotine addiction treatments for entire populations of smokers and for the 80% who are not motivated to quit. Nicotine addiction is just like other drug addictions in terms of breaking the addiction cycle. Researchers and providers differ on whether treatment emphasis should be on clinician-based counseling, biologically-based medications, computer-based tailored communications or a combination of these. There is a lack of comparative research on population treatments to compare effectiveness, cost-effectiveness and enhancement of quality of life. Such comparative research would provide health care systems and providers with evidence on how to best serve entire populations of smokers, especially unmotivated smokers who are seriously underserved. This research will compare the four most highly recommended treatments: 1. Motivation Enhancement Therapy (MET) plus NRT; 2.Tailored communications based on the Transtheoretical Model (TTM), and 3. The combination of these treatments.

Study Type

Interventional

Enrollment (Actual)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Kingston, Rhode Island, United States, 02881
        • University of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Treatment
Behavioral: Integrated Treatment
This enhanced condition would combine MET, Reduction Counseling and NRT and TTM Tailoring.
Other Names:
  • Combined treatment
Experimental: TTM Tailored
Behavioral: TTM Tailored
This treatment is tailored on three occasions (baseline, 6, and 24 weeks) on each of the 14 TTM variables. This treatment provides both normative and ipsative feedback on each of the variables found to predict progress across specific stages
Other Names:
  • TTM Expert System
Experimental: Motivational Enhancement Therapy
Behavioral: Motivational Enhancement Therapy
This intervention will be driven by the manual developed by Carpenter et al. (2004) based on the USPHS recommendations for smokers not motivated to quit and for those who become ready to set a quit date.
Other Names:
  • MET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation (quit) rate
Time Frame: 24 months
Self-report point prevalence abstinence
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rhode Island

Investigators

  • Principal Investigator: James O Prochaska, Ph.D., Univeristy of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DA022291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on TTM Tailored

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe