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Comparing Population Cessation Services

NCT ID: NCT01566994

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Keywords

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smoking cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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TTM Tailored

Group Type EXPERIMENTAL

TTM Tailored

Intervention Type 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

Motivational Enhancement Therapy

Group Type EXPERIMENTAL

Motivational Enhancement Therapy

Intervention Type 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.

Integrated Treatment

Group Type EXPERIMENTAL

Integrated Treatment

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Integrated Treatment

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

Intervention Type BEHAVIORAL

Other Intervention Names

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TTM Expert System MET Combined treatment

Eligibility Criteria

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Inclusion Criteria

* smoker

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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James O. Prochaska

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James O Prochaska, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Rhode Island

Locations

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University of Rhode Island

Kingston, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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DA022291

Identifier Type: -

Identifier Source: org_study_id