Emergency Department Based Management of Tobacco Use Disorder
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- West Virginia University
- Enrollment
- 100
- Primary Endpoint
- Heaviness of Smoking Index (Baseline)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Presenting for evaluation of sexual assault
- •Known allergy or previous intolerance to nicotine replacement therapy
Arms & Interventions
Nicotine Replacement Therapy (NRT)
Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.
Intervention: West Virginia Quit Line (Other)
Control Non NRT Therapy
Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.
Intervention: West Virginia Quit Line (Other)
Nicotine Replacement Therapy (NRT)
Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.
Intervention: Nicotine Replacement Therapy Agent (Combination Product)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Bradley End
Assistant Professor
West Virginia University