A Phase 4 interventional study of Nicotine patch in Cigarette Smoking, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Duke University · Phase 4, Interventional, and Basic science
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Among 11 studies testing Nicotine Patch in Cigarette Smoking — 2 open to participants now, 3 under way, 2 of them phase 3. Nicotine Patch · Cigarette Smoking.
Among the 11 studies testing Nicotine Patch in Cigarette Smoking, this one is the 8th largest by enrollment, is one of 3 that started in 2018, is one of 2 in phase 4, and was the 4th registered.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
Browse Cigarette Smoking studies →2 of the 11 studies testing Nicotine Patch in Cigarette Smoking are open now, in 1 country. Recruiting first, the newest first:
University of Oklahoma · Sites in United States
Ages 21–60 · Healthy volunteers
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Nicotine Patch: first FDA approval 1991 (NICODERM CQ). What it is approved for, and how studies give it, is on its page →
Of the 61 Cigarette Smoking studies recruiting now, 38 (62%) set no upper age limit and 17 (28%) stop at 75 or younger; 1 takes children under 18; 32 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 88 is close to the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Median enrollment 97 across the 11 interventional studies. Of the 6 that completed or were terminated, 6 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 11 has an industry lead sponsor. The 7 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
27 studies in Cigarette Smoking by Duke University: none open now, none under way, none of them phase 3. Of 23 finished, 15 (65%) have results posted.
Among the 27 studies in Cigarette Smoking by Duke University, this one is the 10th largest by enrollment of the 25 interventional ones that give a count, is one of 5 that started in 2018, is one of 3 in phase 4, and was the 22nd registered.
Duke University’s Cigarette Smoking studies by the year they started, since 2007.
2 of the studies testing Nicotine Patch in Cigarette Smoking that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT05587361University of OklahomaBeta-Adrenergic Modulation of Drug Cue Reactivity | 2027-03-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies testing Nicotine Patch in Cigarette Smoking, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Duke University’s 27 in Cigarette Smoking:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this study is to evaluate correlations between brain reactivity (as assessed via functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of smoking in a specific location. The investigators will use ecological momentary assessment (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after quitting smoking. The investigators propose to identify 48 regular cigarette smokers who will complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI session and 4 post-quit medication check sessions). Multiple methods will be used to test hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine correlation between brain responses to smoking environments (minus non-smoking environments) and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global Positioning System (GPS) analysis will primarily focus on locations where smokers smoke before and after quitting smoking. The investigators will evaluate whether EMA-assessed smoking intensity values are correlated with brain responses to these personal smoking environments.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.
Drug: Nicotine patch
Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures
Using fMRI the investigators examined brain function during cue-reactivity. During the scan, participants viewed pictures of personal and non-personal environments. Contrast of parameter estimate (COPE) values for the difference between personal smoking environment pictures and non-personal smoking environment pictures were extracted from anatomically defined brain regions using FSL's featquery for analysis.
Time frame: 4 weeks
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire
EMA will be used to evaluate craving daily for 2 weeks after quitting. Subjects will rate their craving on a single item (How strong is your current urge to smoke?) using a scale from 1 "very slightly or not at all" to 5 "extremely".
Time frame: 2 weeks after quitting smoking
Number of Participants Experiencing Relapse
Relapse defined as 7 consecutive days smoking at least 1 cigarette per day. Individuals lost to contact are presumed to have relapsed following their last visit.
Time frame: Weeks 1, 3, 6, and 10 weeks after quitting.
| Milestone | Nicotine Replacement Therapy |
|---|---|
| Started | 88 |
| Received functional magnetic resonance imaging (fmri) | 42 |
| Completed | 35 |
| Not completed | 53 |
Using fMRI the investigators examined brain function during cue-reactivity. During the scan, participants viewed pictures of personal and non-personal environments. Contrast of parameter estimate (COPE) values for the difference between personal smoking environment pictures and non-personal smoking environment pictures were extracted from anatomically defined brain regions using FSL's featquery for analysis.
| contrast of parameter estimate (COPE) | Nicotine Replacement Therapy |
|---|---|
| Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures | 0.0598 ± 0.09454 |
EMA will be used to evaluate craving daily for 2 weeks after quitting. Subjects will rate their craving on a single item (How strong is your current urge to smoke?) using a scale from 1 "very slightly or not at all" to 5 "extremely".
| score on a scale | Nicotine Replacement Therapy |
|---|---|
| Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire | 2.49 ± 1.03 |
Relapse defined as 7 consecutive days smoking at least 1 cigarette per day. Individuals lost to contact are presumed to have relapsed following their last visit.
| Participants | Nicotine Replacement Therapy |
|---|---|
| Week 1 | 16 |
| Week 3 | 9 |
| Week 6 | 3 |
| Week 10 | 0 |
Collected over 10 weeks after quitting smoking. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nicotine Replacement Therapy | 0/42 (0%) | 0/42 (0%) | 21/42 (50%) |
| Event | Nicotine Replacement Therapy |
|---|---|
| Itching/burning at patch siteSkin and subcutaneous tissue disorders | 8/42 |
| IrritabilityPsychiatric disorders | 8/42 |
| Elevated CESD scorePsychiatric disorders | 7/42 |
| Vivid DreamsPsychiatric disorders | 5/42 |
| CoughingRespiratory, thoracic and mediastinal disorders | 5/42 |
| Rash at Patch siteSkin and subcutaneous tissue disorders | 4/42 |
| HeadacheNervous system disorders | 3/42 |
| InsomniaPsychiatric disorders | 3/42 |
| Heart BurnGastrointestinal disorders | 2/42 |
| NightmaresPsychiatric disorders | 2/42 |
Subjects who completed the study. Those with excessive head motion or artifacts identified during QA checks were not included in analyses.
| Age, Continuous(years) | Nicotine Replacement Therapy |
|---|---|
| Mean | 39.8 ± 11.59 |
| Sex: Female, Male(Participants) | Nicotine Replacement Therapy |
|---|---|
| Female | 14 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | Nicotine Replacement Therapy |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Nicotine Replacement Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 13 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Nicotine Replacement Therapy |
|---|---|
| United States | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Oct 2019, 19 months.
Results were first posted in Dec 2020, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nicotine Patch