Cigarette SmokingPhase 4ProCueNCT03309943

Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity

A Phase 4 study testing Propranolol in people with Cigarette Smoking, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Cigarette Smoking
What is being tested?: Propranolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 16 Jan 2018to 15 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Between the ages of 18 and 55
Generally healthy
Right-handed
Smoke >= 5 cigarettes/day of a brand delivering 0.5 mg nicotine (FTC method)
Have been smoking regularly for >= 1 year, with a stable smoking pattern over the past 6 months
Have an expired CO concentration of >= 10 ppm or urinary cotinine > 100 ng/ml
Are able to identify at least 4 smoking and 4 non-smoking enviornments

Who cannot join

Inability to attend all required sessions
Significant health problems that would interfere with completion of study procedures
Presence of conditions that would make MRI unsafe (e.g. pacemaker)
Presence of exclusionary psychopathology based on MINI interview (current alcohol/substance use disorder moderate or severe pmild is allowable], any history of bipolar disorder or psychosis). Individuals in early remission from substance use disorder (not in a controlled environment) may also be allowed at the PIs discretion
Current use of psychoactive medications per self-report or urine screen. Certain prescribed medications are allowable at the PI's discretion if appropriate documentation (e.g. copy of prescription or physician letter) is provided
Positive breath alcohol concentraiton Pregnant, breastfeeding, or planning to become pregnant during the course of study

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Problems with vision that cannot be corrected with contacts or glasses
Current regular use of smokeless tobacco, smoking cessation medications or non-combustible nicotine products (e.g. e-cigarettes)
Plans to alter smoking pattern (e.g. reduction, uptake, cessation) during course of study
Current use of beta-adrenergic medication
Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg (sitting or standing)
Low resting heart rate (< 60 beats per minute)
Abnormal EKG
Presence of severe anemia (per complete blood count)
Presence of electrolyte imbalance that could impact blood pressure (per metabolic panel)
Presence of any other contraindications for propranolol (e.g. cardiovascular disease, bronchial asthma, prior allergic reaction)
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University School of Medicine
Durham, North Carolina, 27705

Other trials in United States

About this study

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.

Conditions: Cigarette Smoking
Being tested: Propranolol, Placebo
Medical subject headings: Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PropranololDrug
Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
PlaceboDrug
Participants will take one dose of Placebo on two separate occasions.

Study groups in NCT03309943
Study group	Role	What they receive
Propranolol	Experimental	Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions Receives: Drug: Propranolol
Placebo	Placebo comparator	Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: MRI Scan: 2-3 hours post-administration

Secondary outcomes (2)

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.
Measured: 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.
Measured: Lab Task: 2-3 hours post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 201815 Jul 2019

First posted16 Oct 2017
Study start16 Jan 2018
Primary completion15 Jul 2019
Study completion15 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to receive propranolol (40 mg) or placebo
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03309943
Sponsor's protocol ID: Pro00083809
Acronym: ProCue
Status last verified: Jul 2020
First submitted: 10 Oct 2017
Last updated: 13 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cigarette Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity
ClinicalTrials.gov ID: NCT03309943
Acronym / sponsor ID: ProCue / Pro00083809
Conditions: Cigarette Smoking
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 16 Jan 2018 (actual)
Primary completion: 15 Jul 2019 (actual)
Study completion: 15 Jul 2019 (actual)
First posted: 16 Oct 2017 (actual)
Results: Posted 13 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomly assigned to receive propranolol (40 mg) or placebo

Arm	Type	Receives
Propranolol	Experimental	Drug: PropranololPropranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Placebo	Placebo comparator	Drug: PlaceboPlacebo Capsule: No active ingredients, administered 2x at separate laboratory sessions

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Between the ages of 18 and 55
Generally healthy
Right-handed
Smoke >= 5 cigarettes/day of a brand delivering 0.5 mg nicotine (FTC method)
Have been smoking regularly for >= 1 year, with a stable smoking pattern over the past 6 months

Key exclusion criteria (17 listed)

Inability to attend all required sessions
Significant health problems that would interfere with completion of study procedures
Presence of conditions that would make MRI unsafe (e.g. pacemaker)
Presence of exclusionary psychopathology based on MINI interview (current alcohol/substance use disorder moderate or severe pmild is allowable], any history of bipolar disorder or psychosis). Individuals in early remission from substance use disorder (not in a controlled environment) may also be allowed at the PIs discretion
Current use of psychoactive medications per self-report or urine screen. Certain prescribed medications are allowable at the PI's discretion if appropriate documentation (e.g. copy of prescription or physician letter) is provided

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PropranololParticipants will take one dose of Propranolol (40mg IR) on two separate occasions.	Drug	Propranolol
PlaceboParticipants will take one dose of Placebo on two separate occasions.	Drug	Placebo

Primary outcome

BOLD Activation to Smoking Cues - Amygdala
Time frame: MRI Scan: 2-3 hours post-administration
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.
BOLD Activation to Smoking Cues - Anterior Insula
Time frame: MRI Scan: 2-3 hours post-administration
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.
BOLD Activation to Smoking Cues - Anterior Hippocampus
Time frame: MRI Scan: 2-3 hours post-administration
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.
BOLD Activation to Smoking Cues - Posterior Hippocampus
Time frame: MRI Scan: 2-3 hours post-administration
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.
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Time frame: MRI Scan: 2-3 hours post-administration
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.
fMRI BOLD Connectivity
Time frame: MRI Scan: 2-3 hours post-administration
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.
Cue-Provoked Craving - Proximal Cues
Time frame: MRI Scan: 2-3 hours post-administration
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.
Cue-Provoked Craving - Standard Environment Images
Time frame: MRI Scan: 2-3 hours post-administration
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.
Cue-Provoked Craving - Personal Environment Cues
Time frame: MRI Scan: 2-3 hours post-administration
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.

2 secondary outcomes

Laboratory Visit - Self-Reported Craving
Time frame: Lab Task: 2-3 hours post-administration
Laboratory Visit - # Cigarette Puffs
Time frame: Lab Task: 2-3 hours post-administration

Results and safety

Results posted to the registry on 13 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propranolol	22	22
Placebo	22	20

Primary outcome: BOLD Activation to Smoking Cues - Amygdala

Time frame: MRI Scan: 2-3 hours post-administration. Mean (Standard Deviation). Unit: Percent Signal Change

Measure	Propranolol n = 22	Placebo n = 18
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)

Propranolol vs Placebo: p = .019, Mixed Models Analysis

Population analysed: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.

Primary outcome: BOLD Activation to Smoking Cues - Anterior Insula

Time frame: MRI Scan: 2-3 hours post-administration. Mean (Standard Deviation). Unit: Percent Signal Change

Measure	Propranolol n = 22	Placebo n = 18
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)

Propranolol vs Placebo: p = .830, Mixed Models Analysis

Primary outcome: BOLD Activation to Smoking Cues - Anterior Hippocampus

Time frame: MRI Scan: 2-3 hours post-administration. Mean (Standard Deviation). Unit: Percent Signal Change

Measure	Propranolol n = 22	Placebo n = 18
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)

Propranolol vs Placebo: p = .006, Mixed Models Analysis

Primary outcome: BOLD Activation to Smoking Cues - Posterior Hippocampus

Time frame: MRI Scan: 2-3 hours post-administration. Mean (Standard Deviation). Unit: Percent Signal Change

Measure	Propranolol n = 22	Placebo n = 18
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)

Propranolol vs Placebo: p = .653, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propranolol	0 of 22 (0%)	1 of 22 (4.5%)	0 of 22
Placebo	0 of 22 (0%)	1 of 22 (4.5%)	0 of 22

Limitations and caveats (from the sponsor): This was a pilot study with a small sample size. A between-subjects design was used with no baseline scan for comparison. No clinical endpoints were examined - results are limited to neuroimaging and behavioral task outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason A Oliver, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propranolol in people with Cigarette Smoking, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BOLD Activation to Smoking Cues - Amygdala (time frame: MRI Scan: 2-3 hours post-administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03309943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.