Intranasal Insulin for Weight Management During Smoking Cessation

December 7, 2018 updated by: Ajna Hamidovic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • UNM College of Pharmacy
      • Albuquerque, New Mexico, United States
        • UNM College of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount Eaten in Taste Test
Time Frame: 90 minutes
90 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine Cravings Measured by Questionnaire of Smoking Urges
Time Frame: 210 minutes
Range: 7-70. Higher scores mean worse outcome
210 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajna Hamidovic

Investigators

  • Principal Investigator: Ajna Hamidovic, PharmD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

December 10, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120700

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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