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UW Withdraw From Tobacco Study

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Dependence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Tobacco Research and Intervention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nicotine Patch + Nicotine Mini Lozenge

Arm Description

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)

Outcomes

Primary Outcome Measures

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. Cumulative score can vary from 7-133. Higher scores indicate more severe withdrawal symptoms.
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.

Secondary Outcome Measures

Change in WSWS2-L Subscale Score
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. 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.
9-Week Point-Prevalence Abstinence: Y/N
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow up day, confirmed with carbon monoxide reading of less than or equal to 5 ppm.
Change in total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
Self-reported withdrawal symptom severity in the last 24 hours using the Minnesota Tobacco Withdrawal Scale (MTWS). MTWS consists of 17 items. Cumulative score can vary from 0 to 68. Higher scores indicate more severe withdrawal symptoms.

Full Information

First Posted
July 9, 2021
Last Updated
December 8, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04969198
Brief Title
UW Withdraw From Tobacco Study
Official Title
UW Withdraw From Tobacco Study: Enhancing and Evaluating Tobacco Withdrawal Assessment Psychometrics and Validity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine Patch + Nicotine Mini Lozenge
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
Other Intervention Name(s)
C-NRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
Description
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. Cumulative score can vary from 7-133. Higher scores indicate more severe withdrawal symptoms.
Time Frame
pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Title
Change in Wisconsin Smoking Withdrawal Scale2 Brief score
Description
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.
Time Frame
pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Secondary Outcome Measure Information:
Title
Change in WSWS2-L Subscale Score
Description
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. 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.
Time Frame
pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Title
9-Week Point-Prevalence Abstinence: Y/N
Description
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow up day, confirmed with carbon monoxide reading of less than or equal to 5 ppm.
Time Frame
9 weeks after quit date
Title
Change in total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
Description
Self-reported withdrawal symptom severity in the last 24 hours using the Minnesota Tobacco Withdrawal Scale (MTWS). MTWS consists of 17 items. Cumulative score can vary from 0 to 68. Higher scores indicate more severe withdrawal symptoms.
Time Frame
pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesse T Kaye, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Director
Facility Information:
Facility Name
Center for Tobacco Research and Intervention
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators will preregister their study design and publish the study protocol along with the publication of the primary outcome paper. Finally, investigators will make de-identified data and analysis code publicly available on the Open Science Framework (OSF: https://osf.io) or similar platform in accordance with NIH policy and principles of transparent science practices
Links:
URL
https://ctri.wisc.edu/researchers/studies/withdraw-from-tobacco-study/
Description
University of Wisconsin Center for Tobacco Research and Intervention

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