Intranasal Insulin for Weight Management During Smoking Cessation | NCT02028871 | Trialant
CompletedInterventionalPhase 2Updated Dec 10, 2018
Intranasal Insulin for Weight Management During Smoking Cessation
ClinicalTrials.gov ID
NCT02028871
Lead Sponsor
Ajna HamidovicOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
26Actual
Last Update Posted
Dec 10, 2018Actual
Start Date
Jul 2014
Primary Completion Date
May 2016Actual
Completion Date
May 2016Actual
Brief Summary
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.
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