A Phase 4 interventional study of nicotine and placebo in Nicotine Dependence, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Health services research
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.
Smokers recruited for this study are randomly assigned at a screening session to complete the NPU stressor task pre-quit or post-quit (i.e., nicotine deprived or non-deprived). Participants are also randomized to receive either placebo or active combination nicotine replacement therapy (NRT; patches and lozenges) for a two week smoking cessation period. The NPU stressor task measures stressor reactivity to predictable and unpredictable stressors (i.e., electric shock). Startle potentiation during predictable and unpredictable stressors (relative to no-shock) provides the primary measures of stressor reactivity in this task. Predictable and unpredictable startle potentiation are used to calculate overall stressor reactivity and selective unpredictable stressor reactivity. Further detail on these reactivity measures is provided in the Independent Variables section. Detail on the quantification of startle potentiation is provided at the end of this registration.
Smokers provide three weeks (1 week pre-quit, 2 weeks post-quit) of brief 4x daily, real-time web-survey reports of recent cigarette use, NRT use, and other measures not relevant to this study's purpose on the participants' smartphones. At two weeks post-quit, smokers are scheduled for a laboratory visit where participants provide an additional report via staff interview of any smoking during the two-week smoking cessation period.
The stressor reactivity measures from the NPU task will be tested as predictors of clinical outcome (i.e., continuous abstinence during the two-week cessation period) to evaluate the validity of each as surrogate endpoints for use in research on stress mechanisms in smoking relapse. Deprivation status at the time of the NPU stressor task will be examined as a moderator of the effect of stressor reactivity to determine if the surrogate endpoints predict clinical outcome generally or only as deprivation increases.
988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.
This study's enrollment of 226 is above the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.
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Exclusion Criteria:
Additional Data Exclusions
21 mg nicotine patches and 2 mg nicotine lozenges \+ First NPU task takes place 24 hours after start of quit attempt
Combination Product: nicotine
21 mg nicotine patches and 2 mg nicotine lozenges \+ First NPU task takes place during normal smoking prior to quit attempt
Combination Product: nicotine
Placebo patches and placebo lozenges \+ First NPU task takes place 24 hours after start of quit attempt
Other: placebo
Placebo patches and placebo lozenges \+ First NPU task takes place during normal smoking prior to quit attempt
Other: placebo
Overall Stressor Reactivity
The average of unpredictable startle potentiation and predictable startle potentiation during the first administration of the NPU stressor task.
Time frame: up to 24 hours after start of cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)
Relative Unpredictable Stressor Reactivity
Unpredictable startle potentiation minus predictable startle potentiation during the first administration of the NPU stressor task
Time frame: up to 24 hours post cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)
Change in Overall Stressor Reactivity
A difference score of overall stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task
Time frame: baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)
Change in Relative Unpredictable Stressor Reactivity
A difference score of relative unpredictable stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task
Time frame: baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)
| Milestone | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-deprived |
|---|---|---|---|---|
| Started | 53 | 53 | 59 | 61 |
| Completed | 35 | 32 | 34 | 32 |
| Not completed | 18 | 21 | 25 | 29 |
| Withdrew: Withdrawal by subject | 12 | 8 | 21 | 13 |
| Withdrew: Declined due to shock | 1 | 2 | 2 | 3 |
| Withdrew: Protocol violation | 5 | 10 | 2 | 13 |
| Withdrew: Data collection artifact | 0 | 1 | 0 | 0 |
The average of unpredictable startle potentiation and predictable startle potentiation during the first administration of the NPU stressor task.
| microvolts | Active Deprived | Active Non-deprived | Placebo Deprived | Placebo Non-deprived |
|---|---|---|---|---|
| Overall Stressor Reactivity | 25.1 ± 23.0 | 22.5 ± 24.4 | 32.3 ± 29.6 | 16.9 ± 17.7 |
Unpredictable startle potentiation minus predictable startle potentiation during the first administration of the NPU stressor task
| microvolts | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-deprived |
|---|---|---|---|---|
| Relative Unpredictable Stressor Reactivity | -6.77 ± 14.0 | -7.91 ± 14.4 | -6.06 ± 12.3 | -4.99 ± 14.0 |
A difference score of overall stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task
| change in microvolts | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-deprived |
|---|---|---|---|---|
| Change in Overall Stressor Reactivity | -2.94 ± 16.3 | 0.929 ± 13.0 | -10.3 ± 24.0 | 4.78 ± 13.6 |
A difference score of relative unpredictable stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task
| change in microvolts | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-deprived |
|---|---|---|---|---|
| Change in Relative Unpredictable Stressor Reactivity | 1.95 ± 15.5 | 3.99 ± 14.8 | 0.889 ± 16.0 | -1.35 ± 11.3 |
Collected over through 14 days post quit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Deprived | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Active Non-deprived | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Placebo Deprived | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Placebo Non-deprived | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-Deprived | Total |
|---|---|---|---|---|---|
| Mean | 38.1 ± 10.7 | 39.7 ± 12.4 | 40.6 ± 12.3 | 42 ± 11.3 | 40 ± 11.65 |
| Sex: Female, Male(Participants) | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-Deprived | Total |
|---|---|---|---|---|---|
| Female | 14 | 13 | 12 | 11 | 50 |
| Male | 21 | 19 | 22 | 21 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-Deprived | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 0 | 2 |
| Not Hispanic or Latino | 34 | 32 | 33 | 32 | 131 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-Deprived | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 | 1 | 3 |
| Asian | 0 | 01 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 7 | 11 | 9 | 36 |
| White | 26 | 21 | 21 | 21 | 89 |
| More than one race | 0 | 2 | 1 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active Deprived | Active Non-Deprived | Placebo Deprived | Placebo Non-Deprived | Total |
|---|---|---|---|---|---|
| United States | 35 | 32 | 34 | 32 | 133 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD will be shared on the data repository at Open Science Foundation
Supporting information: Study protocol, Analytic code
Time frame: Data will be available on submission of first manuscript based on study
Access criteria: Data are completely open
Data sharing details ↗ · osf.io
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nicotine
University of Wisconsin, Madison →