Intranasal Insulin for Weight Management During Smoking Cessation

Ajna Hamidovic

Status and phase: Completed; Phase 2

Conditions: Tobacco Abstinence Syndrome

Treatments: Drug: Placebo; Drug: Intranasal Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02028871

120700

Details and patient eligibility

About

This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• smokers (>10 cig/day) for the past 1 year
• normosmic olfactory function

Exclusion criteria

• previous/current use of insulin
• current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
• current pregnancy (or lactation)
• lifetime history of endocrine disease
• excessive alcohol use (>25 standard units of alcohol/week)
• current use of illicit drugs
• current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent
• local infections, inflammation, structural abnormalities, or other nasal pathology
• current use of any medications administered intranasally, including intranasal steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups, including a placebo group

Intranasal Insulin First

Active Comparator group

Description:

Intranasal Insulin First, Placebo Second

Treatment:

Drug: Intranasal Insulin

Placebo First

Placebo Comparator group

Description:

Placebo First, Intranasal Insulin Second

Treatment:

Drug: Placebo