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Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

This study is currently recruiting participants.
Verified July 2017 by Ajna Hamidovic, University of New Mexico
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781234
First Posted: January 31, 2013
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ajna Hamidovic, University of New Mexico
January 29, 2013
January 31, 2013
December 4, 2017
August 2013
July 2016   (Final data collection date for primary outcome measure)
episodic memory, salivary cortisol [ Time Frame: 2 years ]
episodic and working memory [ Time Frame: 2 years ]
Complete list of historical versions of study NCT01781234 on ClinicalTrials.gov Archive Site
working memory, continuous attention, psychomotor speed. [ Time Frame: 2 years ]
subjective measure of craving [ Time Frame: 2 years ]
subjective measure of mood and craving [ Time Frame: 2 years ]
subjective measure of mood [ Time Frame: 2 years ]
 
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
December 1, 2017
July 2016   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
United States
 
 
NCT01781234
UNM-246
Yes
Not Provided
Not Provided
Ajna Hamidovic, University of New Mexico
Ajna Hamidovic
Not Provided
Not Provided
University of New Mexico
July 2017

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