Phase 2
N=232
UW Withdraw From Tobacco Study
Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT04969198 ↗Enrolled (actual)
232
Serious AEs
3.5%
Results posted
Dec 2023
Primary outcome: Primary: Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L) — 2.64; 2.36; 2.29; 2.69 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L) |
2.64; 2.36; 2.29; 2.69; 2.73; 2.32 | — |
| PRIMARY Change in Wisconsin Smoking Withdrawal Scale2 Brief Score |
2.69; 2.38; 2.33; 2.74; 2.72; 2.29 | — |
| SECONDARY Change in WSWS2-L Subscale Score : Craving |
4.55; 4.12; 3.98; 4.86; 4.47; 3.3 | — |
| SECONDARY Change in WSWS2-L Subscale Score : Negative Affect |
2.13; 1.95; 1.92; 2.35; 2.48; 2.06 | — |
| SECONDARY Change in WSWS2-L Subscale Score : Concentration |
1.94; 1.73; 1.74; 2.04; 2.18; 1.86 | — |
| SECONDARY Change in WSWS2-L Subscale Score : Sleep Problems |
2.73; 2.35; 2.24; 2.37; 2.55; 2.37 | — |
| SECONDARY Change in WSWS2-L Subscale Score: Hunger |
2.39; 2.19; 2.06; 2.34; 2.44; 2.39 | — |
| SECONDARY Change in WSWS2-L Subscale Score : Restlessness |
2.13; 1.95; 1.92; 2.35; 2.48; 2.06 | — |
| SECONDARY 9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent |
46 | — |
| SECONDARY Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS) |
0.965; 0.855; 0.837; 1.16; 1.2; 1.00 | — |
| SECONDARY Change in WSWS2-L Subscale Score: Anhedonia |
1.93; 1.75; 1.65; 1.91; 2.03; 1.79 | — |
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
Data sourced from ClinicalTrials.gov (NCT04969198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.