Smoking Cessation Clinical Trial
Official title:
Treating Low-Income Smokers in the Hospital Emergency Department
This study will test the effectiveness of an Emergency Department (ED) initiated tobacco
intervention which includes counseling and medication. Our proposed intervention combines a
Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as
well as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine
patches and nicotine gum are provided to subjects in the intervention arm. Subjects
randomized to the control arm will receive a brochure from the state's Smokers' Quitline
only.
The primary hypothesis is that the intervention will be superior to the control condition in
reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.
Status | Completed |
Enrollment | 780 |
Est. completion date | January 2014 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 years - Speaks English - Willing and able to give informed consent - >100 cigarettes lifetime - Current daily or some day smoker - Smokes > 5 cigarettes/day - Medicaid or self-pay insurance Exclusion Criteria: - Too ill or unable to consent - Not interested in study participation - Not interested in quitting - Pregnant, nursing, or trying to conceive - Current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette) - Actively psychotic or mentally ill - Leaving ED against medical advice - Investigator discretion - Lives outside of New Haven County - Does not have phone with CT area code - In police custody - History of allergic reaction to nicotine replacement products - Currently receiving formal tobacco dependence tx - Currently taking Zyban, Wellbutrin (bupropion) or Chantix(varenicline) - Resides in an extended care facility |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemical Verification of Tobacco Abstinence | Biochemical verification means a breathalyzer reading for carbon monoxide. | 3 months after enrollment | No |
Primary | Self-report of Tobacco Abstinence or Reduction | Questionnaires to assess self reported tobacco abstinence | 3 months | No |
Secondary | Self-reported Tobacco Reduction or Abstinence | self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. | 1 month post enrollment | No |
Secondary | Health Care Service Utilization | A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments. | 1 month post enrollment | No |
Secondary | Self-reported Tobacco Reduction or Abstinence | self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. | 12 months post enrollment | No |
Secondary | Health Care Service Utilization | A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments. | 3 months post enrollment | No |
Secondary | Health Care Service Utilization | A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments. | 12 months post enrollment | No |
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