Neuro Biomarkers of Smoking Behavior

NCT03811951 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2017-1288
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Keywords

Tobacco; Cigarettes; Nicotine; Insulin

Outcome Measures

Primary Outcomes (1)

• Go/No-Go Accuracy

  Go/No-Go is used to measure a participants capacity for sustained attention and response control. The test requires a participant to perform an action given certain stimuli (e.g., press a button - Go) and inhibit that action under a different set of stimuli (e.g., not press that same button - No-Go). Average of the 2 runs (run 1 - insulin; run 2 - placebo) were calculated for mean reaction time (+SEM) of smokers and non-smokers on no-go stimuli. The minimum reaction time was 23.08 ms and the maximum reaction time was 97.44 ms. The higher mean value represents slower the reaction time, and the lower mean value represents quicker the reaction time. The higher value means that participants have difficulties with inhibiting a prepotent response. The values do not represent a better or worse outcome.

  From time of drug administration to 70 minutes following drug administration, up to 90 minutes

Study Arms (2)

Smokers

EXPERIMENTAL

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.

Drug: Novolin R

Non-Smokers

EXPERIMENTAL

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.

Drug: Novolin R

Interventions

Novolin R DRUG

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.

Also known as: McKesson Corporation, Novo Nordisk

Non-Smokers; Smokers

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Department of Pharmacy Practice

Chicago, Illinois, 60612, United States

Location

Related Publications (15)

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  PMID: 28242873 BACKGROUND

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  PMID: 10078556 BACKGROUND

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  PMID: 21047524 BACKGROUND

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MeSH Terms

Conditions

Smoking Cessation; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Ajna Hamidovic
• Organization: University of Illinois at Chicago - College of Pharmacy

ahamidov@uic.edu

312-355-1713

Study Officials

• Ajna Hamidovic, PharmD, MS

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: January 22, 2019
• Study Start: September 12, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)