Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

Tobacco Abstinence Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781234
• Other study ID #: UNM-246
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: May 2016

Study information

• Verified date: December 2018
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tobacco Abstinence Syndrome

Intervention

Drug:
• Intranasal Insulin

• Placebo

Locations

Country	Name	City	State
United States	UNM College of Pharmacy	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Ajna Hamidovic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nicotine Craving (Measured by Questionnaire of Smoking Urges)	Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome	90 minutes
Primary	Episodic Memory	California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome	90 minutes
Primary	Salivary Cortisol		90 minutes