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Intranasal Insulin for Weight Management During Smoking Cessation

NCT ID: NCT02028871

Last Updated: 2018-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Abstinence Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intranasal Insulin First

Intranasal Insulin First, Placebo Second

Group Type ACTIVE_COMPARATOR

Intranasal Insulin

Intervention Type DRUG

Placebo First

Placebo First, Intranasal Insulin Second

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Intranasal Insulin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajna Hamidovic

OTHER

Sponsor Role lead

Responsible Party

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Ajna Hamidovic

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ajna Hamidovic, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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UNM College of Pharmacy

Albuquerque, New Mexico, United States

Site Status

UNM College of Pharmacy

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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120700

Identifier Type: -

Identifier Source: org_study_id