Phase 4
N=226
Stress Neuroadaptation in Tobacco Dependence
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03262233 ↗Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Overall Stressor Reactivity — 25.1; 22.5; 32.3; 16.9 microvolts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- nicotine (Combination_product); placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Stressor Reactivity |
25.1; 22.5; 32.3; 16.9 | — |
| PRIMARY Relative Unpredictable Stressor Reactivity |
-6.77; -7.91; -6.06; -4.99 | — |
| PRIMARY Change in Overall Stressor Reactivity |
-2.94; 0.929; -10.3; 4.78 | — |
| PRIMARY Change in Relative Unpredictable Stressor Reactivity |
1.95; 3.99; 0.889; -1.35 | — |
Summary
The objective of the current study is to evaluate the validity of the No Shock, Predictable Shock, Unpredictable Shock (NPU) stressor task for use as a surrogate endpoint to predict short-term clinical outcomes among smokers during a smoking cessation attempt.
Eligibility Criteria
Inclusion Criteria
- cigarette use over 10 cigarettes/day for over two years;
- smoking within the first 30 minutes of waking up
- expired air carbon monoxide (CO) level >6 ppm
- self-reported motivation to quit smoking
- and an agreement to respond to ecological momentary assessment prompts (via SMS) throughout the day for three weeks.
Exclusion Criteria
- Health screening are performed by questionnaire and reviewed by study staff (RA or Research Specialist) to ensure that smokers can safely use the nicotine patch and lozenge. Specifically, smokers will be excluded for FDA contraindications for nicotine replacement therapy (i.e., no uncontrolled hypertension, recent myocardial infarction, diabetes, heart disease, asthma, stomach ulcers).
- All women of child-bearing potential will be required to agree to use an approved method of birth control to prevent pregnancy during the course of the study.
- All participants will report no medical or psychiatric condition that would contraindicate exposure to electric shock.
- Participants with uncorrected auditory or visual problems will be excluded.
Additional Data Exclusions
- As part of the NPU stressor task, smokers are asked to indicate if the participant "can be shocked in the next 5 seconds" at various points during the task. Responses to these questions are used to verify that the participant understands the cue-shock contingencies. Smokers who answer 25% of reports) and no two-week laboratory visit report will be deemed uncertain. These smokers will be excluded and replaced.
- The investigators will conduct case analyses to identify participants who are model outliers with Bonferroni-corrected studentized residuals p < 0.05. These model outliers will be excluded but NOT replaced (because the participants are not identified until after data collection has been completed).
Data sourced from ClinicalTrials.gov (NCT03262233). 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.