Neuro Biomarkers of Smoking Behavior

• Status: Terminated
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Illinois at Chicago
• Treatments: Insulin; Insulin, Globin Zinc

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