Clinical trial NCT01123967: Offering Proactive Tobacco Treatment
Official title: Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: nicotine replacement therapy
smoking cessation
tobacco dependent
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-14
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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).

Primary outcomes:
measure: Results in Abstinence Rates
timeFrame: 1 Year
Secondary outcomes:
measure: Results in Treatment Utilization
timeFrame: 1 Year
measure: Cost-Effectiveness of Program
timeFrame: 1 Year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Steven Fu, M.D.
state: Minnesota
Study officials:
affiliation: Veterans Administration Hospital
name: Steven Fu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Masonic Cancer Center, University of Minnesota
name: Anne Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.
citation: Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.
citation: Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.
citation: Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.