Neuro Biomarkers of Smoking Behavior
Condition: Smoking Cessation
Intervention: Novolin R
Intervention description: Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: The University of Illinois Hospital and Health Sciences System Investigational Drug Service (IDS) randomizes treatment order to study subjects and prepares drug product and placebo. All other roles, including participant, investigator, and non-IDS study personnel are masked from treatment order.
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco; Cigarettes; Nicotine; Insulin

Summary:

      The purpose of this study is to evaluate cognition in smokers and nonsmokers. It involves
      administration of intranasal insulin (Novolin R), an investigational medication followed by a
      brief non-invasive cognitive test. All participants will receive both Novolin R and placebo
      in two separate testing sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 21-40 years

          -  Smokers only: Begin smoking within 5 minutes of waking (verified by carbon monoxide
             concentrations greater than 10 ppm).

          -  Non-smokers only: No self-reported cigarette use in the past 1-year period.

          -  Non-smokers only: Carbon monoxide concentration < 6 ppm.

          -  Normal vitals (blood pressure < 120/80 mmHg; heart rate between 60 and 100 bpm, body
             temperature <37 °C)

          -  Point-of-care (POC) blood glucose between 80 and 140 mg/dL

          -  Body mass index between 18.5 and 30 kg/m2

        Exclusion Criteria:

          -  Use of non-cigarette tobacco products, e-cigarettes, or smoking cessation treatment

          -  Positive urine drug screen test

          -  Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant

          -  Breath Alcohol Concentration >0.00%

          -  Shipley IQ (Intelligence Quotient) test <80

          -  Hyposmic or anosmic individuals (identifying less than 10 of 12 smells correctly)

          -  Abnormal physical exam of the nares

          -  Lifetime DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) Axis 1
             disorder (except anxiety and depression)

          -  Current DSM-5 Axis depression or anxiety disorder

          -  Prescription medications

          -  Over-the-counter psychotropic medications

          -  Use of any medications administered intranasally

          -  Allergies to any ingredients in intranasal insulin or placebo

          -  Braided hair that would cause noise in EEG recording