Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

Ajna Hamidovic

Status and phase: Completed; Phase 2

Conditions: Tobacco Abstinence Syndrome

Treatments: Drug: Intranasal Insulin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01781234

UNM-246

Details and patient eligibility

About

This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.

Enrollment: 51 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: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

Intranasal Insulin

Experimental group

Description:

Intranasal Insulin

Treatment:

Drug: Intranasal Insulin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo