Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

Ajna Hamidovic51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tobacco Abstinence Syndrome

Interventions

Intranasal InsulinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UNM College of Pharmacy

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

Episodic Memory

California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome

Time frame: 90 minutes

Salivary Cortisol

Time frame: 90 minutes

Data from ClinicalTrials.gov

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