Comparing Population Cessation Services

Cancer Clinical Trial

Official title:

Comparing Population Cessation Services With Emphasis on Unmotivated Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566994
• Other study ID #: DA022291
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: September 16, 2013
• Start date: March 2010
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: University of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smoker

Exclusion Criteria:

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Rhode Island	Kingston	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation (quit) rate	Self-report point prevalence abstinence	24 months	No