RecruitingPhase 4

Beta-Adrenergic Modulation of Drug Cue Reactivity

United States80 participantsStarted 2024-11-26

Plain-language 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.

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Cue-Provoked Craving Ratings

Timeframe: Approximately 4-5 hours

Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues

Timeframe: Approximately 4-5 hours

Association between Smoking Urge and Brain Activation

Timeframe: Approximately 4-5 hours

Hippocampus-Amygdala connectivity to smoking cues

Timeframe: Approximately 4-5 hours

Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity

Timeframe: Approximately 4-5 hours

Association between Smoking Urge and Brain Connectivity

Timeframe: Approximately 4-5 hours

Trial details

NCT IDNCT05587361

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Jason A Oliver, PhD

405-271-8001 Jason-Oliver@ouhsc.edu

View on ClinicalTrials.gov More Tobacco Use Disorder trials

Plain-language summary

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Cue-Provoked Craving Ratings

Timeframe: Approximately 4-5 hours

Blood-Oxygen Level Dependent (BOLD) Activation to Smoking Cues

Timeframe: Approximately 4-5 hours

Association between Smoking Urge and Brain Activation

Timeframe: Approximately 4-5 hours

Hippocampus-Amygdala connectivity to smoking cues

Timeframe: Approximately 4-5 hours

Medial Prefrontal Cortex and Posterior Cingulate Cortex connectivity

Timeframe: Approximately 4-5 hours

Association between Smoking Urge and Brain Connectivity

Timeframe: Approximately 4-5 hours