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Completed

NCT Number: NCT01299896

Connect to Quit for Smoking

The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.

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Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Cigarette Smoking Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15206, United States

About this study

Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female 18 years or older
  • Veterans seen by a primary care physician within the VAPHS
  • Household income not more than $36,000 annually
  • Smoke at least 1 cigarette per day

Exclusion criteria

  • Smokeless tobacco (snuff or chew) users
  • Non-cigarette (e.g., pipe) smokers
  • Non-English speaking patients
  • Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment

Treatment and study plan

Coordinated care

Other

CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.

Other names: Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, Intervention, Nicotine Replacement, Buproprion, Wellbutrin, Chantix, Varenicline, Behavorial therapy

Usual Care

Other

Standard therapy to help participants with smoking cessation.

Other names: Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, Intervention, Nicotine Replacement, Buproprion, Wellbutrin, Chantix, Varenicline, Behavorial therapy

Primary outcomes

  1. Effectiveness of CTQ vs UC

    Time frame: Two (2) year period

    We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans

Acronym: CTQ

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2011
Registry last updated
Mar 22, 2016

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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