NCT01781234

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 10, 2018

Completed
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

January 29, 2013

Results QC Date

December 1, 2017

Last Update Submit

December 7, 2018

Conditions

Tobacco Abstinence Syndrome

Outcome Measures

Primary Outcomes (2)

  • Episodic Memory

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

    90 minutes

  • Salivary Cortisol

    90 minutes

Other Outcomes (1)

  • Nicotine Craving (Measured by Questionnaire of Smoking Urges)

    90 minutes

Study Arms (2)

Intranasal Insulin

EXPERIMENTAL

Intranasal Insulin

Drug: Intranasal Insulin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Intranasal InsulinDRUG
Intranasal Insulin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smokers (\>10 cig/day) for the past 1 year
  • normosmic olfactory function

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNM College of Pharmacy

Albuquerque, New Mexico, 87131, United States

Location

Results Point of Contact

Title
Dr. Ajna Hamidovic
Organization
University of Illinois College of Pharmacy
ahamidov@uic.edu
312-355-1713

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 31, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

December 10, 2018

Results First Posted

December 10, 2018

Record last verified: 2018-12

Locations

US(1)