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Completed

NCT Number: NCT01781234

Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

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.

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Key information

Conditions

Tobacco Abstinence Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UNM College of Pharmacy

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal insulin

Drug

Placebo

Drug

Primary outcomes

  1. Episodic Memory

    Time frame: 90 minutes

    California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome

  2. Salivary Cortisol

    Time frame: 90 minutes

Other outcomes

  1. Nicotine Craving (Measured by Questionnaire of Smoking Urges)

    Time frame: 90 minutes

    Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome

Sponsors and collaborators

Lead sponsor

Ajna Hamidovic

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 31, 2013
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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