Text Size

Comparing Population Cessation Services

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James O. Prochaska, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01566994
First received: January 31, 2012
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Cancer
 Behavioral: TTM Tailored
Behavioral: Motivational Enhancement Therapy
Behavioral: Integrated Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Comparing Population Cessation Services With Emphasis on Unmotivated Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • Smoking cessation (quit) rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Self-report point prevalence abstinence


Enrollment: 2500
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: MET
Experimental: Integrated Treatment Behavioral: Integrated Treatment
This enhanced condition would combine MET, Reduction Counseling and NRT and TTM Tailoring.
Other Name: Combined 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.

  Eligibility

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

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566994

Locations
United States, Rhode Island
University of Rhode Island
Kingston, Rhode Island, United States, 02881
Sponsors and Collaborators
University of Rhode Island
Investigators
Principal Investigator: James O Prochaska, Ph.D. Univeristy of Rhode Island
  More Information

No publications provided

Responsible Party: James O. Prochaska, Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01566994     History of Changes
Other Study ID Numbers: DA022291
Study First Received: January 31, 2012
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
smoking cessation

ClinicalTrials.gov processed this record on June 17, 2013