Neuro Biomarkers of Smoking Behavior

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT03811951

Run by

University of Illinois at Chicago

People needed

4

Starts

2018-09-12

Expected to finish

2019-09-27

Last updated by the study team

2021-03-02

Who can join

Age: 21 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Illinois Department of Pharmacy Practice — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.