A Phase 4 interventional study of Propranolol and Placebo in Cigarette Smoking, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Duke University · Phase 4, Interventional, and Basic science
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Among 27 studies in Cigarette Smoking by Duke University — none open to participants now, none under way, none of them phase 3. Cigarette Smoking · Duke University.
Among the 27 studies in Cigarette Smoking by Duke University, this one is the 12th 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 21st registered.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
Browse Cigarette Smoking studies →None of the 27 studies in Cigarette Smoking by Duke University is open now. The open studies under Cigarette Smoking, anywhere →
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 55 Years · all sexes · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 8 · Phase 3 4 · Phase 4 3
First in 2007; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 44 is below the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Median enrollment 40 across the 25 interventional studies, 110 across the 2 observational. Of the 23 that completed or were terminated, 15 (65%) have results posted.
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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.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Cigarette Smoking by Duke University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The central objective of this project is to obtain proof-of-concept data demonstrating the effects of propranolol (a beta-adrenergic antagonist) on neurobiological responses to personal smoking environments and behavioral responses in a laboratory smoking behavior task. Human cigarette smokers (N = 50) will take photographs of locations where they do and do not smoke cigarettes. They will then be randomly assigned to receive either propranolol (40 mg) or placebo prior to completing: A) An MRI session assessing neural responses to personal smoking/non-smoking environments, standard smoking/non-smoking environments and proximal smoking/non-smoking cues; and B) A laboratory session examining smoking behavior in response to environmental cues.
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:
Note that the above criteria reflect general guidelines for decision-making, but ultimate determinations are left to the discretion of the study physician. Presence of minor (e.g. asymptomatic bradycardia in the range of 50-60 in an otherwise healthy adult) or transient (e.g. electrolyte imbalance readily addressed via changes in fluid intake) may still be deemed eligible to participate.
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 recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Drug: Propranolol
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Drug: Placebo
Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
Participants will take one dose of Placebo on two separate occasions.
BOLD Activation to Smoking Cues - Amygdala
BOLD activation in amygdala (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Time frame: MRI Scan: 2-3 hours post-administration
BOLD Activation to Smoking Cues - Anterior Insula
BOLD activation in Anterior Insula (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Time frame: MRI Scan: 2-3 hours post-administration
BOLD Activation to Smoking Cues - Anterior Hippocampus
BOLD activation in Anterior Hippocampus (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Time frame: MRI Scan: 2-3 hours post-administration
BOLD Activation to Smoking Cues - Posterior Hippocampus
BOLD activation in Posterior Hippocampus (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Time frame: MRI Scan: 2-3 hours post-administration
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
BOLD activation in Medial Prefrontal Cortex (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Time frame: MRI Scan: 2-3 hours post-administration
fMRI BOLD Connectivity
Connectivity with right amygdala when viewing proximal smoking images, using a right anterior hippocampus seed region (psychophysiological interaction analysis; PPI). Larger values represent greater connectivity between these regions while viewing proximal smoking images.
Time frame: MRI Scan: 2-3 hours post-administration
Cue-Provoked Craving - Proximal Cues
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
Time frame: MRI Scan: 2-3 hours post-administration
Cue-Provoked Craving - Standard Environment Images
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
Time frame: MRI Scan: 2-3 hours post-administration
Cue-Provoked Craving - Personal Environment Cues
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
Time frame: MRI Scan: 2-3 hours post-administration
Laboratory Visit - Self-Reported Craving
Self-reported craving to smoke following presentation of personal smoking environments (prior to ad-lib smoking period). Assessed using the average rating across four questions drawn from the Questionnaire on Smoking Urges: (1) While focusing on those places...nothing would have been better than smoking a cigarette; (2) While focusing on those places...I had the urge for a cigarette; (3) While focusing on those places...all I wanted right then was a cigarette; (4) While focusing on those places...I craved a cigarette. Participants rated each item on an 11-point scale ranging from 0 (Do not agree) to 100 (Strongly agree) in 10-point intervals. These ratings were averaged across items for analysis. higher values represent greater craving. Tiffany, S. T., \& Drobes, D. J. (1991). The development and initial validation of a questionnaire on smoking urges. British Journal of addiction, 86(11), 1467-1476.
Time frame: Lab Task: 2-3 hours post-administration
Laboratory Visit - # Cigarette Puffs
Number of cigarette puffs taken during ad lib smoking period while participants view images of their personal smoking environment. Smoking was video recorded and puffs were coded by two raters.
Time frame: Lab Task: 2-3 hours post-administration
Participants were enrolled in a laboratory setting at Duke University School of Medicine during a period ranging from January 2018 to June 2019.
| Milestone | Propranolol | Placebo |
|---|---|---|
| Started | 22 | 22 |
| Completed | 22 | 20 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Inappropriate behavior towards staff | 0 | 1 |
BOLD activation in amygdala (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
| Percent Signal Change | Propranolol | Placebo |
|---|---|---|
| Non-Smoking Personal Environments | 0.002471 ± 0.367038 | 0.077325 ± 0.337887 |
| Smoking Personal Environments | 0.009450 ± 0.384823 | 0.090345 ± 0.293101 |
| Non-Smoking Standard Environments | 0.044903 ± 0.352711 | 0.042836 ± 0.341324 |
| Smoking Standard Environments | 0.111746 ± 0.321235 | 0.161114 ± 0.355927 |
| Non-Smoking Proximal | 0.066409 ± 0.386921 | 0.015171 ± 0.353829 |
| Smoking Proximal | 0.025432 ± 0.378728 | 0.133363 ± 0.409809 |
BOLD activation in Anterior Insula (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
| Percent Signal Change | Propranolol | Placebo |
|---|---|---|
| Non-Smoking Personal Environments | -0.179076 ± 0.288539 | -0.157851 ± 0.281748 |
| Smoking Personal Environments | -0.127730 ± 0.293581 | -0.142636 ± 0.269551 |
| Non-Smoking Standard Environments | -0.118271 ± 0.317144 | -0.152299 ± 0.326875 |
| Smoking Standard Environments | -0.146114 ± 0.312662 | -0.149887 ± 0.282468 |
| Non-Smoking Proximal | -0.085715 ± 0.331652 | -0.085873 ± 0.270967 |
| Smoking Proximal | -0.086867 ± 0.352310 | -0.098181 ± 0.318646 |
BOLD activation in Anterior Hippocampus (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
| Percent Signal Change | Propranolol | Placebo |
|---|---|---|
| Non-Smoking Personal Environments | 0.061001 ± 0.324934 | 0.095120 ± 0.271027 |
| Smoking Personal Environments | 0.073925 ± 0.300800 | 0.088399 ± 0.267232 |
| Non-Smoking Standard Environments | 0.133369 ± 0.315323 | 0.083638 ± 0.277520 |
| Smoking Standard Environments | 0.171673 ± 0.289132 | 0.186590 ± 0.300916 |
| Non-Smoking Proximal | 0.088852 ± 0.323655 | 0.000827 ± 0.280219 |
| Smoking Proximal | 0.024626 ± 0.296327 | 0.095598 ± 0.291577 |
BOLD activation in Posterior Hippocampus (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
| Percent Signal Change | Propranolol | Placebo |
|---|---|---|
| Non-Smoking Personal Environments | 0.161077 ± 0.288481 | 0.185521 ± 0.262021 |
| Smoking Personal Environments | 0.156684 ± 0.303924 | 0.166154 ± 0.252282 |
| Non-Smoking Standard Environments | 0.137124 ± 0.304769 | 0.161655 ± 0.241679 |
| Smoking Standard Environments | 0.179651 ± 0.256910 | 0.176196 ± 0.269538 |
| Non-Smoking Proximal | 0.056247 ± 0.281092 | 0.053026 ± 0.271871 |
| Smoking Proximal | 0.050077 ± 0.260461 | 0.121240 ± 0.262651 |
BOLD activation in Medial Prefrontal Cortex (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
| Percent Signal Change | Propranolol | Placebo |
|---|---|---|
| Non-Smoking Personal Environments | 0.033030 ± 0.322540 | 0.012705 ± 0.409304 |
| Smoking Personal Environments | 0.058184 ± 0.378236 | 0.060320 ± 0.313844 |
| Non-Smoking Standard Environments | -0.078483 ± 0.350182 | -0.167025 ± 0.447513 |
| Smoking Standard Environments | -0.068693 ± 0.311347 | -0.093598 ± 0.447743 |
| Non-Smoking Proximal | -0.039529 ± 0.362686 | -0.109172 ± 0.422732 |
| Smoking Proximal | -0.064034 ± 0.345958 | 0.015524 ± 0.413311 |
Connectivity with right amygdala when viewing proximal smoking images, using a right anterior hippocampus seed region (psychophysiological interaction analysis; PPI). Larger values represent greater connectivity between these regions while viewing proximal smoking images.
| PPI Index | Propranolol | Placebo |
|---|---|---|
| fMRI BOLD Connectivity | -0.0740 ± 0.0769 | 0.0228 ± 0.0997 |
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
| units on a scale | Propranolol | Placebo |
|---|---|---|
| Non-Smoking | 2.866883 ± 1.566946 | 1.898148 ± 0.824614 |
| Smoking | 6.103084 ± 1.618450 | 6.547619 ± 1.685597 |
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
| units on a scale | Propranolol | Placebo |
|---|---|---|
| Non-Smoking | 2.673052 ± 1.681618 | 1.763889 ± 0.644389 |
| Smoking | 4.666937 ± 1.588874 | 4.868056 ± 1.716846 |
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
| units on a scale | Propranolol | Placebo |
|---|---|---|
| Non-Smoking | 3.369318 ± 1.802147 | 2.965278 ± 1.668703 |
| Smoking | 6.045996 ± 1.457661 | 6.638889 ± 1.569405 |
Self-reported craving to smoke following presentation of personal smoking environments (prior to ad-lib smoking period). Assessed using the average rating across four questions drawn from the Questionnaire on Smoking Urges: (1) While focusing on those places...nothing would have been better than smoking a cigarette; (2) While focusing on those places...I had the urge for a cigarette; (3) While focusing on those places...all I wanted right then was a cigarette; (4) While focusing on those places...I craved a cigarette. Participants rated each item on an 11-point scale ranging from 0 (Do not agree) to 100 (Strongly agree) in 10-point intervals. These ratings were averaged across items for analysis. higher values represent greater craving. Tiffany, S. T., \& Drobes, D. J. (1991). The development and initial validation of a questionnaire on smoking urges. British Journal of addiction, 86(11), 1467-1476.
| units on a scale | Propranolol | Placebo |
|---|---|---|
| Laboratory Visit - Self-Reported Craving | 7.3 ± 2.7 | 7.9 ± 3.0 |
Number of cigarette puffs taken during ad lib smoking period while participants view images of their personal smoking environment. Smoking was video recorded and puffs were coded by two raters.
| Puffs | Propranolol | Placebo |
|---|---|---|
| Laboratory Visit - # Cigarette Puffs | 15.2 ± 7.1 | 17.7 ± 9.8 |
Collected over This is an acute administration study with an approved medication with a well-established safety profile. Adverse events were assessed over the 1-3 month period in which participants were engaged in the project, primarily for purposes of ensuring new contraindications did not emerge prior to drug administration vs concerns about adverse events related to the drug itself.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propranolol | 0/22 (0%) | 0/22 (0%) | 1/22 (4.5%) |
| Placebo | 0/22 (0%) | 0/22 (0%) | 1/22 (4.5%) |
| Event | Propranolol | Placebo |
|---|---|---|
| Dog BiteSkin and subcutaneous tissue disorders | 1/22 | 0/22 |
| Wrist InjuryMusculoskeletal and connective tissue disorders | 0/22 | 1/22 |
Participants who completed the study.
| Age, Continuous(years) | Propranolol | Placebo | Total |
|---|---|---|---|
| Mean | 37.6 ± 9.6 | 35.0 ± 10.4 | 36.3 ± 10.0 |
| Sex: Female, Male(Participants) | Propranolol | Placebo | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 11 | 9 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Propranolol | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 22 | 19 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Propranolol | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 11 | 20 |
| White | 11 | 7 | 18 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Cigarettes Per Day(Cigarettes/day) | Propranolol | Placebo | Total |
|---|---|---|---|
| Mean | 15.0 ± 6.1 | 15.4 ± 7.3 | 15.2 ± 6.6 |
| Fagerstrom Test for Cigarette Dependence(units on a scale) | Propranolol | Placebo | Total |
|---|---|---|---|
| Mean | 4.2 ± 1.7 | 5.4 ± 2.2 | 4.8 ± 2.0 |
| Contemplation Ladder (Motivation to Quit)(units on a scale) | Propranolol | Placebo | Total |
|---|---|---|---|
| Mean | 4.9 ± 2.5 | 3.3 ± 2.9 | 4.1 ± 2.8 |
| Number of Previous Quit Attempts(quit-attempts) | Propranolol | Placebo | Total |
|---|---|---|---|
| Mean | 2.5 ± 2.3 | 2.0 ± 1.6 | 2.2 ± 2.0 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with HIPAA requirements (as well as university data security policies), all data will be de-identified according to HIPAA guidelines prior to being shared. Personal images themselves will not be made publicly available due to privacy concerns. However, a brief description of each image (e.g. "Front porch of home") will be made available. Data would be provided in widely accessible formats (e.g. csv/xls), along with a detailed data dictionary describing all elements and coding and study protocols.
Supporting information: Study protocol
Time frame: We anticipate making data available within six months of study completion. It will be available for an indefinite period of time.
Access criteria: Contact PI for details
Ran from Jan 2018 to primary completion in Jul 2019, 17 months.
Results were first posted in Aug 2020, 1 year after primary completion.
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Studies of the drug tested here: Propranolol