Neuro Biomarkers of Smoking Behavior

University of Illinois

Status and phase: Terminated; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: Novolin R

Study type: Interventional

Funder types: Other

Identifiers

NCT03811951

2017-1288

Details and patient eligibility

About

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.

Full description

This program of research focuses on identifying neurologic biomarkers of smoking behavior in order to develop individualized smoking cessation aids. The intranasal insulin administered is an investigational drug and has been granted IND status by the FDA (IND#129432). During the times of drug effects, the investigators will evaluate a biomarker using computerized tasks. Non-smokers and smokers will participate in two testing sessions where the biomarker will be critically evaluated after administration of intranasal insulin and compared to the cognitive processes elicited by placebo administration.

Enrollment: 4 patients

Sex: All

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Smokers

Experimental group

Description:

All participants receive both Novolin R (experimental drug) and 14% NaCl (Sodium Chloride) solution (placebo), to be administered in randomly assigned order on two separate testing sessions. During administration of either Novolin R or 14% NaCl, participants will receive 1 spray in each nostril every 3 minutes for a total of 6 sprays. The nasal spray bottle delivers 0.1 ml of liquid per spray. Since the concentration of insulin in Novolin R is 100 IU/mL, six sprays will deliver a 60 IU dose.

Treatment:

Drug: Novolin R

Non-Smokers

Experimental group

Description:

All participants receive both Novolin R (experimental drug) and 14% NaCl solution (placebo), to be administered in randomly assigned order on two separate testing sessions. During administration of either Novolin R or 14% NaCl, participants will receive 1 spray in each nostril every 3 minutes for a total of 6 sprays. The nasal spray bottle delivers 0.1 ml of liquid per spray. Since the concentration of insulin in Novolin R is 100 IU/mL, six sprays will deliver a 60 IU dose.

Treatment:

Drug: Novolin R