Emergency Department Based Management of Tobacco Use Disorder
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Tobacco Use Disorder
- Sponsor
- West Virginia University
- Enrollment
- 100
- Primary Endpoint
- Heaviness of Smoking Index (Baseline)
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.
Investigators
Bradley End
Assistant Professor
West Virginia University
Eligibility Criteria
Inclusion Criteria
- •Current daily use cigarettes greater than or equal to ½ pack per day
- •Stable for discharge from the ED
- •Able and willing to complete telephone/electronic follow up at scheduled intervals
- •Reported English speaking
Exclusion Criteria
- •Patients enrolled in specific health insurance plans (PEIA, The Health Plan or Medicaid medical insurance)
- •WVU students
- •Medically unstable patients
- •Patients with clinical decompensation or who are admitted to the hospital
- •Patients who are discharged to residential treatment facilities for detoxification
- •Uncontrolled psychiatric disorder or psychiatric emergency
- •Individuals who are unable to provide consent
- •Incarcerated individuals
- •Language barrier
- •Currently pregnant or attempting to become pregnant
Outcomes
Primary Outcomes
Heaviness of Smoking Index (Baseline)
Time Frame: Baseline
A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, \>5 is severe)
Percentage of Continued Abstinence Rate (1 month)
Time Frame: 1 Month post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 1 month from initial dose given during the ED visit.
Patient Health Questionnaire 2 (Baseline)
Time Frame: Baseline
A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression.
Percentage of Continued Abstinence Rate (2 weeks)
Time Frame: 2 Weeks post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 2 weeks from initial dose given during the ED visit.
Percentage of Continued Abstinence Rate (3 months)
Time Frame: 3 Months post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 3 months from initial dose given during the ED visit.
Heaviness of Smoking Index (3 months from baseline)
Time Frame: 3 months from baseline
A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, \>5 is severe)
Richmond Test (3 months from baseline)
Time Frame: 3 months from baseline
A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit.
Patient Health Questionnaire 2 (3 months from baseline)
Time Frame: 3 months from baseline
A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression.
Richmond Test (Baseline)
Time Frame: Baseline
A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit.