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Intranasal Insulin for Weight Management During Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02028871
Recruitment Status : Completed
First Posted : January 7, 2014
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ajna Hamidovic, University of New Mexico

Study Description
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Brief Summary:
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intranasal Insulin First
Intranasal Insulin First, Placebo Second
 Drug: Intranasal Insulin
Placebo Comparator: Placebo First
Placebo First, Intranasal Insulin Second
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Amount Eaten in Taste Test [ Time Frame: 90 minutes ]

Other Outcome Measures:
  1. Nicotine Cravings Measured by Questionnaire of Smoking Urges [ Time Frame: 210 minutes ]
    Range: 7-70. Higher scores mean worse outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Contacts and Locations
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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): NCT02028871


Locations
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United States, New Mexico
UNM College of Pharmacy
Albuquerque, New Mexico, United States, 87131
UNM College of Pharmacy
Albuquerque, New Mexico, United States
Sponsors and Collaborators
Ajna Hamidovic
Investigators
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Principal Investigator: Ajna Hamidovic, PharmD University of New Mexico
More Information
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Responsible Party: Ajna Hamidovic, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT02028871    
Other Study ID Numbers: 120700
First Posted: January 7, 2014    Key Record Dates
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs