Tobacco Use Cessation, Tobacco Use Disorder
Conditions
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.
Interventions
COMBINATION_PRODUCTNicotine Replacement Therapy Agent
The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (\ 210).
OTHERWest Virginia Quit Line
Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Continued Abstinence Rate (2 weeks) | 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 (1 month) | 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. |
| Percentage of Continued Abstinence Rate (3 months) | 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. |
| Patient Health Questionnaire 2 (Baseline) | 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. |
| Patient Health Questionnaire 2 (3 months from baseline) | 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. |
| Heaviness of Smoking Index (Baseline) | 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) |
| Heaviness of Smoking Index (3 months from baseline) | 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 (Baseline) | 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. |
| Richmond Test (3 months from baseline) | 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. |
Outcome results
None listed