CompletedInterventionalPhase 4Updated Aug 16, 2019
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome | NCT01781234 | Trialant
CompletedInterventionalPhase 2Updated Dec 10, 2018
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
ClinicalTrials.gov ID
NCT01781234
Lead Sponsor
Ajna HamidovicOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
51Actual
Last Update Posted
Dec 10, 2018Actual
Start Date
Aug 2013
Primary Completion Date
May 2016Actual
Completion Date
May 2016Actual
Brief 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.
Tobacco Abstinence Syndrome
Intranasal Insulin
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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