Beta-Adrenergic Modulation of Drug Cue Reactivity
2 other identifiers
interventional
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2024
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedStudy Start
First participant enrolled
November 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
April 28, 2026
April 1, 2026
2.3 years
October 3, 2022
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
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.
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
Approximately 4-5 hours
Association between Smoking Urge and Brain Activation
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Approximately 4-5 hours
Hippocampus-Amygdala connectivity to smoking cues
Index of connectivity between these brain regions
Approximately 4-5 hours
Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity
Index of connectivity between these brain regions
Approximately 4-5 hours
Association between Smoking Urge and Brain Connectivity
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Approximately 4-5 hours
Study Arms (4)
Placebo Patch/Placebo Propranolol
PLACEBO COMPARATORPlacebo Nicotine Patch Placebo Propranolol
Placebo Patch/Active Propranolol
EXPERIMENTALPlacebo Nicotine Patch Active Propranolol (40 mg, immediate release)
Active Patch/Placebo Propranolol
EXPERIMENTALActive Nicotine Patch (14 mg) Placebo Propranolol
Active Patch/Active Propranolol
EXPERIMENTALActive Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release)
Interventions
Propranolol Capsule; 40 mg IR
Nicotine Patch; 14 mg
Placebo Capsule, no active ingredients
Placebo Patch, no active ingredients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- Duke Universitycollaborator
- Oklahoma State University Center for Health Sciencescollaborator
- National Institute on Drug Abuse (NIDA)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Hardesty Center for Clinical Research and Neuroscience
Tulsa, Oklahoma, 74136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason A Oliver, PhD
University of Oklahoma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2022
First Posted
October 20, 2022
Study Start
November 26, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04