Tobacco Use DisorderPhase 4NCT06350175
Emergency Department Management of Tobacco Use Disorder
A Phase 4 study testing Nicotine Replacement Therapy Agent and West Virginia Quit Line in people with Tobacco Use Disorder and Tobacco Use Cessation, run by West Virginia University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Use Disorder, Tobacco Use Cessation
- What is being tested?
- Nicotine Replacement Therapy Agent and West Virginia Quit Line
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Emergency Department Based Management of Tobacco Use Disorder
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
- Being tested
- Nicotine Replacement Therapy Agent, West Virginia Quit Line
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: West Virginia Quit Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Lack of participant/departmental interest. Nearing end of pilot grant award.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley End, West Virginia University
- Investigators
- Bradley End, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350175
- Sponsor's protocol ID
- 2212697123
- Status last verified
- Dec 2024
- First submitted
- 1 Apr 2024
- Last updated
- 2 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Based Management of Tobacco Use Disorder
- ClinicalTrials.gov ID
- NCT06350175
- Acronym / sponsor ID
- 2212697123
- Conditions
- Tobacco Use Disorder, Tobacco Use Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participant/departmental interest. Nearing end of pilot grant award.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy (NRT) | Active comparator | Combination Product: Nicotine Replacement Therapy Agent, Other: West Virginia Quit LineSubject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information. |
| Control Non NRT Therapy | Other | Other: West Virginia Quit LineSubject will be provided with a box/bag containing a WV QL fact sheet/contact information. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy AgentThe NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (~210). | Combination product | Nicotine Replacement Therapy (NRT) |
| West Virginia Quit LineInstructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking. | Other | Control Non NRT Therapy, Nicotine Replacement Therapy (NRT) |
Primary outcome
Percentage of Continued Abstinence Rate (2 weeks)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley End principal investigator
West Virginia University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Therapy Agent and West Virginia Quit Line in people with Tobacco Use Disorder and Tobacco Use Cessation, run by West Virginia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Continued Abstinence Rate (2 weeks) (time frame: 2 Weeks post initial dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2025.