Neurobehavioral Substrates of Proranolol's Effects on Drug Cue Reactivity

Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - 55
Start Date:January 16, 2018
End Date:August 31, 2019
Contact:Bryana Roberts, BS

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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.

Inclusion Criteria:

- Generally healthy

- Right-handed

- Smoke an average of 5 or more cigarettes per day of a brand delivering at least 0.5 mg

- Have been smoking regularly for at least 2 years, with a stable smoking pattern over
the past 6 months

- FTND score of 4 or greater at screening

- Afternoon expired CO concentration of at least 10 ppm or morning urinary cotinine >
100 ng/ml

Exclusion Criteria:

- Inability to attend all required sessions

- Significant health problems that would interfere with completion of study procedures

- MRI contraindications (e.g. pacemaker, metal implants)

- Presence of exclusionary psychopathology based on a structured clinical interview
(current alcohol/substance use disorder moderate or severe [mild 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
PI's 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 is provided (e.g. copy of prescription or physician letter)

- Positive breath alcohol concentration

- 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 other
non-combustible nicotine products

- Plans to alter smoking pattern (e.g. reduction, cessation) during the course of study

- Current use of beta adrenergic medication

- Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg (sitting or

- Low resting heart rate (< 60 bpm)

- Abnormal EKG

- Presence of severe anemia

- Presence of electrolyte imbalance that impact blood pressure

- Presence of any other contraindications for propranolol (e.g. cardiovascular disease,
bronchial asthma, prior allergic reaction to propranolol)
We found this trial at
Durham, North Carolina 27710
Principal Investigator: Jason A Oliver, PhD
Phone: 919-684-7601
Durham, NC
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