Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity
Condition: Cigarette Smoking
Intervention: Propranolol; Placebo
Intervention description: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.; Participants will take one dose of Placebo on two separate occasions.
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive propranolol (40 mg) or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.