Emergency Department Management of Tobacco Use Disorder

West Virginia University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Tobacco Use Disorder Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy AgentCOMBINATION_PRODUCT

The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (\~210).

West Virginia Quit LineOTHER

Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Continued Abstinence Rate (2 weeks)

Percentage of subjects who self-report continued abstinence in tobacco use at 2 weeks from initial dose given during the ED visit.

Time frame: 2 Weeks post initial dose

Percentage of Continued Abstinence Rate (1 month)

Percentage of subjects who self-report continued abstinence in tobacco use at 1 month from initial dose given during the ED visit.

Time frame: 1 Month post initial dose

Percentage of Continued Abstinence Rate (3 months)

Percentage of subjects who self-report continued abstinence in tobacco use at 3 months from initial dose given during the ED visit.

Time frame: 3 Months post initial dose

Patient Health Questionnaire 2 (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.

Time frame: Baseline

Patient Health Questionnaire 2 (3 months from baseline)

Time frame: 3 months from baseline

Heaviness of Smoking Index (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)

Time frame: Baseline

Heaviness of Smoking Index (3 months from baseline)

Data from ClinicalTrials.gov

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