Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Tobacco Abstinence Syndrome
Drug: Intranasal Insulin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • episodic memory, salivary cortisol [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • working memory, continuous attention, psychomotor speed. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • subjective measure of mood and craving [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal Insulin
Intranasal Insulin
Drug: Intranasal Insulin
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ajna Hamidovic, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01781234     History of Changes
Other Study ID Numbers: UNM-246
Study First Received: January 29, 2013
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014