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Completed

NCT Number: NCT01123967

Offering Proactive Tobacco Treatment

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).

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior Smoking Cessation

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steven Fu, M.D.

Minneapolis, Minnesota, 55417, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

proactive outreach (PRO)

Other

a mailed invitation letter followed by telephone outreach

telephone counseling (TC)

Other

free telephone counseling

Nicotine replacement therapy (NRT)

Other

free nicotine replacement therapy (NRT)

Usual Care (UC)

Other

nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Cost-Effectiveness of Program

    Time frame: 1 Year

    Determine the cost-effectiveness of PRO+NRT+TC compared with UC.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 14, 2010
Registry last updated
May 27, 2015

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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