Beta-Adrenergic Modulation of Drug Cue Reactivity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Generally healthy
Age 21-60
Right-handed using a three-item scale
Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Propranolol
DrugPropranolol Capsule; 40 mg IR
Nicotine Patch
DrugNicotine Patch; 14 mg
Placebo Propranolol
DrugPlacebo Capsule, no active ingredients
Placebo Patch
DrugPlacebo Patch, no active ingredients
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Placebo Patch/Placebo PropranololPlacebo comparator 2 interventions
Group B: Placebo Patch/Active PropranololExperimental treatment 2 interventions
Group C: Active Patch/Placebo PropranololExperimental treatment 2 interventions
Group D: Active Patch/Active PropranololExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 4-5 hours2
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
Time frame
Approximately 4-5 hours3
Association between Smoking Urge and Brain Activation
Indices of covariation between cue-provoked craving BOLD activation to smoking cues
Time frame
Approximately 4-5 hours4
Hippocampus-Amygdala connectivity to smoking cues
Index of connectivity between these brain regions
Time frame
Approximately 4-5 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oklahoma
Lead sponsor
Oklahoma State University Center for Health Sciences
Collaborator
Duke University
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov