Comparing Population Cessation Services

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566994
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : September 17, 2013
Information provided by (Responsible Party):
James O. Prochaska, University of Rhode Island

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Behavioral: TTM Tailored Behavioral: Motivational Enhancement Therapy Behavioral: Integrated Treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Comparing Population Cessation Services With Emphasis on Unmotivated Smokers
Study Start Date : March 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/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 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

Primary Outcome Measures :
  1. Smoking cessation (quit) rate [ Time Frame: 24 months ]
    Self-report point prevalence abstinence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566994

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

Responsible Party: James O. Prochaska, Professor, University of Rhode Island Identifier: NCT01566994     History of Changes
Other Study ID Numbers: DA022291
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by James O. Prochaska, University of Rhode Island:
smoking cessation