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Offering Proactive Tobacco Treatment

Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01123967
Enrollment
2500
Registered
2010-05-14
Start date
2011-02-28
Completion date
2014-08-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Cessation

Keywords

nicotine replacement therapy, smoking cessation, tobacco dependent

Brief summary

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).

Detailed description

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

Interventions

OTHERproactive outreach (PRO)

a mailed invitation letter followed by telephone outreach

OTHERtelephone counseling (TC)

free telephone counseling

OTHERNicotine replacement therapy (NRT)

free nicotine replacement therapy (NRT)

OTHERUsual care (UC)

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Results in Abstinence Rates1 YearCompare 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

MeasureTime frameDescription
Results in Treatment Utilization1 YearCompare 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 Program1 YearDetermine the cost-effectiveness of PRO+NRT+TC compared with UC.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026