Tobacco Use DisorderPhase 4NCT05587361
Beta-Adrenergic Modulation of Drug Cue Reactivity
A Phase 4 study testing Propranolol and Nicotine Patch in people with Tobacco Use Disorder and Nicotine Dependence, run by University of Oklahoma at 1 site in United States.
Trial summary
This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Nicotine Dependence, Cigarette Smoking
- What is being tested?
- Propranolol and Nicotine Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Age 21-60
- Right-handed using a three-item scale
- Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
- Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months
- Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and/or morning urinary cotinine >100 ng/ml
- Must identity at least 4 different smoking locations used in a typical week
- Able to read and understand English
Who cannot join
- Inability to attend all required sessions
- Significant health problems that would preclude active participation
- Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)
- Current use of psychoactive medications/drugs as indicated by self-report or urine screen
- Positive breath alcohol concentration
- Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)
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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 other nicotine containing products (e.g. electronic cigarettes)
- Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications
- Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg (sitting or standing)
- Abnormal EKG
- Presence of severe anemia
- Presence of electrolyte imbalance that could impact blood pressure
- Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Isabel Brush, B.A. contact
United States1 site, 1 recruiting
- Recruiting
Hardesty Center for Clinical Research and Neuroscience
Tulsa, Oklahoma, 74136
Isabel Brush, B.A., Isabel-Brush@ouhsc.edu
Rebecca Gonzalez, B.A., Rebecca-Gonzalez@ouhsc.edu
About this study
Official title: Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms
This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.
Read the detailed description
Cigarette use remains a serious public health problem in the United States and worldwide. Effective pharmacological interventions for smoking cessation exist, but these medications primarily target nicotine withdrawal and smoking reinforcement. The cues and contexts associated with smoking also play an important role in driving smoking behavior, but evidence is extremely mixed whether existing interventions can effectively attenuate smoking urges and behavior in response to these cues and contexts.
In a previous pilot trial, the investigators demonstrated that propranolol suppressed smoking cue reactivity and brain activation across a constellation of brain regions implicated in nicotine dependence. Here, the investigators seek to extend this work by examining effects when the drug is administered in combination with an established treatment targeting withdrawal and reinforcement (i.e., nicotine patch).
Following consent and screening/baseline activities, participants will attend four neuroimaging appointments each lasting approximately 5 hours. Participants will be fitted with a nicotine or placebo patch, fed a standard meal and then administered propranolol or placebo. Participants will complete questionnaires and have their heart rate/blood pressure monitored throughout the visit. During the MRI scan, participants will be asked to complete both resting scans and task-based scans during which participants will view images of smoking and non-smoking objects and scenes.
- Conditions
- Tobacco Use Disorder, Nicotine Dependence, Cigarette Smoking
- Being tested
- Propranolol, Nicotine Patch, Placebo Propranolol, Placebo Patch
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Propranolol Capsule; 40 mg IR
Nicotine PatchDrug
Nicotine Patch; 14 mg
Placebo PropranololDrug
Placebo Capsule, no active ingredients
Placebo PatchDrug
Placebo Patch, no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Placebo Patch/Placebo Propranolol | Placebo comparator | Placebo Nicotine Patch Placebo Propranolol Receives: Drug: Placebo Propranolol; Drug: Placebo Patch |
| Placebo Patch/Active Propranolol | Experimental | Placebo Nicotine Patch Active Propranolol (40 mg, immediate release) Receives: Drug: Propranolol; Drug: Placebo Patch |
| Active Patch/Placebo Propranolol | Experimental | Active Nicotine Patch (14 mg) Placebo Propranolol Receives: Drug: Nicotine Patch; Drug: Placebo Propranolol |
| Active Patch/Active Propranolol | Experimental | Active Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release) Receives: Drug: Propranolol; Drug: Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-Provoked Craving Ratings
Self-reported smoking urges in response to smoking and non-smoking cues during magnetic resonance imaging (MRI) scan. Scores range from 0 to 10 with higher values indicating increased craving for cigarettes.
Measured: Approximately 4-5 hours
Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues
Blood-Oxygen Level Dependent (BOLD) Contrast (Smoking-Neutral) in Anterior Hippocampus, Amygdala, Dorsal Anterior Insula, Medial Prefrontal Cortex, Posterior Cingulate Cortex and Ventral Striatum
Measured: Approximately 4-5 hours
Association between Smoking Urge and Brain Activation
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Measured: Approximately 4-5 hours
Hippocampus-Amygdala connectivity to smoking cues
Index of connectivity between these brain regions
Measured: Approximately 4-5 hours
Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity
Index of connectivity between these brain regions
Measured: Approximately 4-5 hours
Association between Smoking Urge and Brain Connectivity
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Measured: Approximately 4-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start26 Nov 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University Center for Health Sciences, Duke University, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jason A Oliver, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587361
- Sponsor's protocol ID
- 2022005-OSU-CHS
- Other IDs
- 1R01DA053342-01A1
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms
- ClinicalTrials.gov ID
- NCT05587361
- Acronym / sponsor ID
- 2022005-OSU-CHS
- Conditions
- Tobacco Use Disorder, Nicotine Dependence, Cigarette Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma State University Center for Health Sciences, Duke University, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.
Detailed description
Cigarette use remains a serious public health problem in the United States and worldwide. Effective pharmacological interventions for smoking cessation exist, but these medications primarily target nicotine withdrawal and smoking reinforcement. The cues and contexts associated with smoking also play an important role in driving smoking behavior, but evidence is extremely mixed whether existing interventions can effectively attenuate smoking urges and behavior in response to these cues and contexts.
In a previous pilot trial, the investigators demonstrated that propranolol suppressed smoking cue reactivity and brain activation across a constellation of brain regions implicated in nicotine dependence. Here, the investigators seek to extend this work by examining effects when the drug is administered in combination with an established treatment targeting withdrawal and reinforcement (i.e., nicotine patch).
Following consent and screening/baseline activities, participants will attend four neuroimaging appointments each lasting approximately 5 hours. Participants will be fitted with a nicotine or placebo patch, fed a standard meal and then administered propranolol or placebo. Participants will complete questionnaires and have their heart rate/blood pressure monitored throughout the visit. During the MRI scan, participants will be asked to complete both resting scans and task-based scans during which participants will view images of smoking and non-smoking objects and scenes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Patch/Placebo Propranolol | Placebo comparator | Drug: Placebo Propranolol, Drug: Placebo PatchPlacebo Nicotine Patch Placebo Propranolol |
| Placebo Patch/Active Propranolol | Experimental | Drug: Propranolol, Drug: Placebo PatchPlacebo Nicotine Patch Active Propranolol (40 mg, immediate release) |
| Active Patch/Placebo Propranolol | Experimental | Drug: Nicotine Patch, Drug: Placebo PropranololActive Nicotine Patch (14 mg) Placebo Propranolol |
| Active Patch/Active Propranolol | Experimental | Drug: Propranolol, Drug: Nicotine PatchActive Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Generally healthy
- Age 21-60
- Right-handed using a three-item scale
- Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
- Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months
Key exclusion criteria (14 listed)
- Inability to attend all required sessions
- Significant health problems that would preclude active participation
- Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)
- Current use of psychoactive medications/drugs as indicated by self-report or urine screen
- Positive breath alcohol concentration
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 |
|---|---|---|
| PropranololPropranolol Capsule; 40 mg IR | Drug | Active Patch/Active Propranolol, Placebo Patch/Active Propranolol |
| Nicotine PatchNicotine Patch; 14 mg | Drug | Active Patch/Active Propranolol, Active Patch/Placebo Propranolol |
| Placebo PropranololPlacebo Capsule, no active ingredients | Drug | Active Patch/Placebo Propranolol, Placebo Patch/Placebo Propranolol |
| Placebo PatchPlacebo Patch, no active ingredients | Drug | Placebo Patch/Active Propranolol, Placebo Patch/Placebo Propranolol |
Primary outcome
Cue-Provoked Craving Ratings
Time frame: Approximately 4-5 hours
Self-reported smoking urges in response to smoking and non-smoking cues during magnetic resonance imaging (MRI) scan. Scores range from 0 to 10 with higher values indicating increased craving for cigarettes.
Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues
Time frame: Approximately 4-5 hours
Blood-Oxygen Level Dependent (BOLD) Contrast (Smoking-Neutral) in Anterior Hippocampus, Amygdala, Dorsal Anterior Insula, Medial Prefrontal Cortex, Posterior Cingulate Cortex and Ventral Striatum
Association between Smoking Urge and Brain Activation
Time frame: Approximately 4-5 hours
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Hippocampus-Amygdala connectivity to smoking cues
Time frame: Approximately 4-5 hours
Index of connectivity between these brain regions
Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity
Time frame: Approximately 4-5 hours
Index of connectivity between these brain regions
Association between Smoking Urge and Brain Connectivity
Time frame: Approximately 4-5 hours
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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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.
Isabel Brush, B.A. contact
Jason A Oliver, PhD principal investigator
University of Oklahoma
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 and Nicotine Patch in people with Tobacco Use Disorder and Nicotine Dependence, run by University of Oklahoma 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason A Oliver, PhD (405-271-8001 ext. 14005, Jason-Oliver@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cue-Provoked Craving Ratings (time frame: Approximately 4-5 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.