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Completed

NCT Number: NCT01566994

Comparing Population Cessation Services

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.

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rhode Island

Kingston, Rhode Island, 02881, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • smoker

Exclusion criteria

  • pregnancy

Treatment and study plan

TTM Tailored

Behavioral

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

Motivational Enhancement Therapy

Behavioral

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

Integrated Treatment

Behavioral

This enhanced condition would combine MET, Reduction Counseling and NRT and TTM Tailoring.

Other names: Combined treatment

Primary outcomes

  1. Smoking cessation (quit) rate

    Time frame: 24 months

    Self-report point prevalence abstinence

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Registry information

Official study title

Comparing Population Cessation Services With Emphasis on Unmotivated Smokers

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 30, 2012
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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