Print Friendly Page

Protocol No. UW20070

Principal Investigator Fiore, Michael

Phase N/A

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed

Title Health Systems Reach Interventions Project

Objective The ultimate objective of this project is to help more smokers stop smoking

Treatment Randomly assigned to have access to treatment that includes both coaching and medication. The coaching includes 3 phone calls with a trained stop-smoking coach. These 20-minute calls will be one week before your quit day, on the day after your quit day, and one week after your quit day. In addition, if your doctor agrees that medication is right for you, you will receive 12 weeks of medication that has been shown to at least double the chances of quitting successfully in past studies. The medications are Varenicline(Chantix) and or a combination of nicotine patches and mini-lozenge

Description Breathe 2 Project 2: Centralized Health System Interventions to Enhance Reach: A Factorial Screening Experiment

Key Eligibility Inclusion criteria for study participation:
  • Age greater than 17 years
  • On smoking registry at a participating clinic
  • Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
  • Able to participate in informed consent activities (reports understanding the nature of the study and consent)
  • Able to speak and read English
    Inclusion criteria for access to intensive treatment (randomization on 4th factor):
  • Smoke at least 5 cigarettes per day on average for at least 6 months at enrollment
  • Ability to meet screening criteria for one or both of the enhanced medication regimens, varenicline and/or combination NRT
    Exclusion criteria for study participation:
  • Opted out of recruitment at the most recent clinic visit, or by patient-initiated contact
  • Willing to quit smoking within the next 30 days at recruitment call
  • Activated healthcare power of attorney or cognitive impairment that would preclude informed consent Exclusion criteria for access to intensive treatment (randomization on 4th factor):
  • Can not be pregnancy, breastfeeding, or unwillingness to use an approved method of birth control as defined by the protocol
  • Contraindications to both varenicline and nicotine patch and mini-lozenge

  • Applicable Disease Sites Unknown Sites

    Status Open

    Participating Institutions UW Hospital and Clinics