Clinical trial NCT04969198: UW Withdraw From Tobacco Study
Official title: UW Withdraw From Tobacco Study: Enhancing and Evaluating Tobacco Withdrawal Assessment Psychometrics and Validity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Dependence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-07-20
Enrollment: 232
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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

Primary outcomes:
measure: Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Secondary outcomes:
measure: Change in WSWS2-L Subscale Score : Craving
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in WSWS2-L Subscale Score : Negative Affect
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in WSWS2-L Subscale Score : Concentration
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in WSWS2-L Subscale Score : Sleep Problems
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in WSWS2-L Subscale Score: Hunger
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in WSWS2-L Subscale Score : Restlessness
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: 9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent
timeFrame: 9 weeks after quit date
measure: Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
measure: Change in WSWS2-L Subscale Score: Anhedonia
timeFrame: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy B Baker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Jesse T Kaye, PhD
role: STUDY_DIRECTOR
References: