NCT01566994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

January 31, 2012

Last Update Submit

September 16, 2013

Conditions

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation (quit) rate

    Self-report point prevalence abstinence

    24 months

Study Arms (3)

TTM Tailored

EXPERIMENTAL
Behavioral: TTM Tailored

Motivational Enhancement Therapy

EXPERIMENTAL
Behavioral: Motivational Enhancement Therapy

Integrated Treatment

EXPERIMENTAL
Behavioral: Integrated Treatment

Interventions

TTM TailoredBEHAVIORAL

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

Also known as: TTM Expert System
TTM Tailored

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.

Also known as: MET
Motivational Enhancement Therapy

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

Also known as: Combined treatment
Integrated Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoker

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

MeSH Terms

Conditions

NeoplasmsSmoking Cessation

Interventions

Motivational InterviewingCombined Modality Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesTherapeutics

Study Officials

  • James O Prochaska, Ph.D.

    Univeristy of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2012

First Posted

March 30, 2012

Study Start

March 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations