Emergency Department Management of Tobacco Use Disorder

Phase 4

Withdrawn

• Conditions: Tobacco Use Disorder; Tobacco Use Cessation
• Interventions: Other: West Virginia Quit Line; Combination Product: Nicotine Replacement Therapy Agent

• Registration Number: NCT06350175
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Study Start: 2024-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-02
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Non NRT Therapy	West Virginia Quit Line	Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.
Nicotine Replacement Therapy (NRT)	West Virginia Quit Line	Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.
Nicotine Replacement Therapy (NRT)	Nicotine Replacement Therapy Agent	Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.

Primary Outcome Measures

Name	Time	Method
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)
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.
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.
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 (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.
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 (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.
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.
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.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States