Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity

Completed · Phase 4 · Has a placebo group

Conditions studied: Cigarette Smoking

In brief

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.

Key facts

Study ID

NCT03309943

Run by

Duke University

People needed

44

Starts

2018-01-16

Expected to finish

2019-07-15

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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.

Where it is running

• Duke University School of Medicine — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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