Emergency Department Management of Tobacco Use Disorder

NCT06350175 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2212697123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tobacco Use Disorder; Tobacco Use Cessation

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.

Combination Product: Nicotine Replacement Therapy Agent; Other: West Virginia Quit Line

Control Non NRT Therapy

OTHER

Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.

Other: West Virginia Quit Line

Interventions

Nicotine Replacement Therapy Agent COMBINATION_PRODUCT

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

Nicotine Replacement Therapy (NRT)

West Virginia Quit Line OTHER

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

Control Non NRT Therapy; Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Bradley End

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 2, 2025

Record last verified: 2024-12