Phase 2
Completed N=26
Intranasal Insulin for Weight Management During Smoking Cessation
Tobacco Abstinence Syndrome
Source: ClinicalTrials.gov NCT02028871 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Amount Eaten in Taste Test — 124; 116 grams
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount Eaten in Taste Test |
124; 116 | — |
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
Data sourced from ClinicalTrials.gov (NCT02028871). 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.