Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

This study is currently recruiting participants.
Verified December 2013 by University of New Mexico
Sponsor:
Information provided by (Responsible Party):
Ajna Hamidovic, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01781234
First received: January 29, 2013
Last updated: December 20, 2013
Last verified: December 2013

January 29, 2013
December 20, 2013
August 2013
June 2015   (final data collection date for primary outcome measure)
episodic memory, salivary cortisol [ Time Frame: 2 years ] [ Designated as safety issue: No ]
episodic and working memory [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01781234 on ClinicalTrials.gov Archive Site
working memory, continuous attention, psychomotor speed. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
subjective measure of craving [ Time Frame: 2 years ] [ Designated as safety issue: No ]
subjective measure of mood and craving [ Time Frame: 2 years ] [ Designated as safety issue: No ]
subjective measure of mood [ Time Frame: 2 years ] [ Designated as safety issue: No ]
 
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Tobacco Abstinence Syndrome
  • Drug: Intranasal Insulin
  • Drug: Placebo
  • Experimental: Intranasal Insulin
    Intranasal Insulin
    Intervention: Drug: Intranasal Insulin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Not Provided
United States
 
NCT01781234
UNM-246
Yes
Ajna Hamidovic, University of New Mexico
Ajna Hamidovic
Not Provided
Not Provided
University of New Mexico
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP