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Offering Proactive Tobacco Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123967
First Posted: May 14, 2010
Last Update Posted: May 27, 2015
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).

Condition Intervention
Tobacco Use Cessation Other: proactive outreach (PRO) Other: telephone counseling (TC) Other: Nicotine replacement therapy (NRT) Other: Usual care (UC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Results in Abstinence Rates [ Time Frame: 1 Year ]
    Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers.


Secondary Outcome Measures:
  • Results in Treatment Utilization [ Time Frame: 1 Year ]
    Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers.

  • Cost-Effectiveness of Program [ Time Frame: 1 Year ]
    Determine the cost-effectiveness of PRO+NRT+TC compared with UC.


Enrollment: 2500
Study Start Date: February 2011
Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRO+NRT+TC
Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC)
Other: proactive outreach (PRO)
a mailed invitation letter followed by telephone outreach
Other: telephone counseling (TC)
free telephone counseling
Other: Nicotine replacement therapy (NRT)
free nicotine replacement therapy (NRT)
Active Comparator: Usual Care (UC)
Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray
Other: Usual care (UC)
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

Detailed Description:
Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must complete the baseline survey
  • Current self-reported cigarette smoker
  • Has a valid home address
  • An adequate proficiency in English to complete study surveys and participate in telephone counseling.

exclusion Criteria:

  • adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01123967


Locations
United States, Minnesota
Steven Fu, M.D.
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Fu, M.D. Veterans Administration Hospital
Principal Investigator: Anne Joseph, MD Masonic Cancer Center, University of Minnesota
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01123967     History of Changes
Other Study ID Numbers: 2009NTLS064
0909S72235 ( Other Identifier: IRB, University of Minnesota )
1R01CA141527 ( U.S. NIH Grant/Contract )
First Submitted: May 12, 2010
First Posted: May 14, 2010
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
nicotine replacement therapy
smoking cessation
tobacco dependent

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action