Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01781234
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ajna Hamidovic, University of New Mexico

Tracking Information
First Submitted Date  ICMJE January 29, 2013
First Posted Date  ICMJE January 31, 2013
Results First Submitted Date  ICMJE December 1, 2017
Results First Posted Date  ICMJE December 10, 2018
Last Update Posted Date December 10, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • Episodic Memory [ Time Frame: 90 minutes ]
    California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome
  • Salivary Cortisol [ Time Frame: 90 minutes ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
episodic and working memory [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
subjective measure of craving [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures
 (submitted: December 7, 2018)
Nicotine Craving (Measured by Questionnaire of Smoking Urges) [ Time Frame: 90 minutes ]
Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome
Original Other Pre-specified Outcome Measures
 (submitted: January 29, 2013)
subjective measure of mood [ Time Frame: 2 years ]
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Abstinence Syndrome
Intervention  ICMJE
  • Drug: Intranasal Insulin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Intranasal Insulin
    Intranasal Insulin
    Intervention: Drug: Intranasal Insulin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2018)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2013)
75
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01781234
Other Study ID Numbers  ICMJE UNM-246
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ajna Hamidovic, University of New Mexico
Study Sponsor  ICMJE Ajna Hamidovic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of New Mexico
Verification Date December 2018

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