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Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

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ClinicalTrials.gov Identifier: NCT01781234
Recruitment Status : Recruiting
First Posted : January 31, 2013
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ajna Hamidovic, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Tobacco Abstinence Syndrome Drug: Intranasal Insulin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2013
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intranasal Insulin
Intranasal Insulin
Drug: Intranasal Insulin
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. episodic memory, salivary cortisol [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. working memory, continuous attention, psychomotor speed. [ Time Frame: 2 years ]

Other Outcome Measures:
  1. subjective measure of mood and craving [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781234


Locations
United States, New Mexico
UNM College of Pharmacy Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Ajna Hamidovic, PharmD    505-272-4742    ahamidovic@salud.unm.edu   
Principal Investigator: Ajna Hamidovic, PharmD, MS         
Sponsors and Collaborators
Ajna Hamidovic

Responsible Party: Ajna Hamidovic, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01781234     History of Changes
Other Study ID Numbers: UNM-246
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs