Phase 2 Completed N=51 Randomized Double-blind Treatment

Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

Tobacco Abstinence Syndrome

Source: ClinicalTrials.gov NCT01781234 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcomePrimary: Episodic Memory — 11.6; 10.0 number of words recalled

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Episodic Memory	11.6; 10.0	—
PRIMARY Salivary Cortisol	0.23; 0.13	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01781234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.