- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781234
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
December 7, 2018 updated by: Ajna Hamidovic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
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
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- 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
Yes
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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Experimental: Intranasal Insulin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Episodic Memory
Time Frame: 90 minutes
|
California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome
|
90 minutes
|
Salivary Cortisol
Time Frame: 90 minutes
|
90 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2013
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
January 29, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 31, 2013
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
- UNM-246
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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