UW Withdraw From Tobacco Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-09-21

Brief Summary

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It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings.

Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).

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Detailed Description

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Conditions

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Tobacco Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nicotine Patch + Nicotine Mini Lozenge

No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.

Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)

Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)

Group Type EXPERIMENTAL

Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)

Intervention Type DRUG

Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.

Interventions

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Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)

Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.

Intervention Type DRUG

Other Intervention Names

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C-NRT

Eligibility Criteria

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Inclusion Criteria

* Smoke ≥5 cigarettes per day for past year
* ≥21 years old
* Able to read and write English
* Desire to quit smoking
* Not currently engaged in cessation treatment
* Eligible to use combination nicotine replacement therapy
* Willing and able to attend study visits
* Have reliable smartphone access
* Not currently pregnant, trying to get pregnant, or breastfeeding
* Willing to respond to ecological momentary assessment prompts and other study activities
* Baseline breath carbon monoxide (CO) ≥5ppm

Exclusion Criteria

* Used pipe tobacco, cigars, snuff, or chew more than twice in the past week
* Used e-cigarette, vaping, or any other electronic nicotine delivery product more than twice in the past week
* Unwilling to try to abstain from all non-medicinal nicotine use (including e-cigarettes) for the duration of the Cessation Phase (other than nicotine replacement therapy provided by the study)
* Currently taking varenicline or bupropion
* Allergy to adhesive tape
* Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it
* Unwilling to use study approved methods of birth control while taking study medication and for 1 month after discontinuing study medication \[only for women of child-bearing potential\]
* Hospitalized for a stroke, heart attack, congestive heart failure, ulcers, or diabetes within the last year
* History of seizure within the last year
* Diagnosis of and/or treatment for schizophrenia, other psychotic disorders, or bipolar disorder within the last 5 years
* End-stage renal disease
* Suicide attempt or suicidal ideation within the last 12 months
* Severe hypertension \> 180/100 mmHg

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes