Emergency Department Management of Tobacco Use Disorder

Tobacco Use Disorder Clinical Trial

Official title:

Emergency Department Based Management of Tobacco Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350175
• Other study ID #: 2212697123
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: West Virginia University
• Contact: Bradley End, MD
• Phone: 304 293 9565
• Email: bradley.end[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Combination Product:
• Nicotine Replacement Therapy Agent
The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (~210).

Other:
• West 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.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 Weeks post initial dose
Primary	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.	1 Month post initial dose
Primary	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.	3 Months post initial dose
Primary	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.	Baseline
Primary	Patient Health Questionnaire 2 (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.	3 months from baseline
Primary	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)	Baseline
Primary	Heaviness of Smoking Index (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)	3 months from baseline
Primary	Richmond Test (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.	Baseline
Primary	Richmond Test (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.	3 months from baseline