UW Withdraw From Tobacco Study

NCT04969198 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: 2020-0792A534253SMPH/MEDICINE/GEN INT MD5R01HL109031Protocol Version 2/21/2022
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (2)

• Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)

  Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version. WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

• Change in Wisconsin Smoking Withdrawal Scale2 Brief Score

  Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Brief Version. WSWS-2 consists of 6 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Higher scores indicate more severe withdrawal symptoms.

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

Secondary Outcomes (9)

• Change in WSWS2-L Subscale Score : Craving

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

• Change in WSWS2-L Subscale Score : Negative Affect

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

• Change in WSWS2-L Subscale Score : Concentration

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

• Change in WSWS2-L Subscale Score : Sleep Problems

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

• Change in WSWS2-L Subscale Score: Hunger

  pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

Study Arms (1)

Nicotine Patch + Nicotine Mini Lozenge

EXPERIMENTAL

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)

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

Interventions

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

Also known as: C-NRT

Nicotine Patch + Nicotine Mini Lozenge

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

Related Links

• University of Wisconsin Center for Tobacco Research and Intervention

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Jesse Kaye
• Organization: University of Wisconsin-Madison

jtkaye@ctri.wisc.edu

608-262-8885

Study Officials

• Timothy B Baker, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Jesse T Kaye, PhD

  University of Wisconsin, Madison

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: July 13, 2021
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: May 8, 2025
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)