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Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01522963
First received: January 17, 2012
Last updated: July 30, 2014
Last verified: July 2014

January 17, 2012
July 30, 2014
December 2011
January 2014   (final data collection date for primary outcome measure)
Craving [ Time Frame: During the 1 hour period after exposure to stressful task ] [ Designated as safety issue: No ]
The craving increase that occurs when smokers are exposed to a stressful task will be measured
Same as current
Complete list of historical versions of study NCT01522963 on ClinicalTrials.gov Archive Site
Nicotine withdrawal symptoms [ Time Frame: During the 1 hour period after exposure to stressful task ] [ Designated as safety issue: No ]
The increase in nicotine withdrawal symptoms that occurs when smokers are exposed to a stressful task will be measured
Same as current
Not Provided
Not Provided
 
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Tobacco Use Disorder
Drug: Nicotine lozenge 4 mg
A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
  • Experimental: Nicotine lozenge prior to stress task
    Subjects will receive the nicotine lozenge at one of four time-points prior to the stress task at the first laboratory session and after the stress task at the second laboratory session
    Intervention: Drug: Nicotine lozenge 4 mg
  • Active Comparator: Nicotine lozenge after stress task
    Subjects will receive the nicotine lozenge after the stress task during the first laboratory session and prior to the stress task at the second laboratory session
    Intervention: Drug: Nicotine lozenge 4 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Smoking an average of at least 10 cigarette per day
  • General good health

Exclusion Criteria:

  • unstable medical or psychiatric conditions
  • history of severe motion sickness
  • women who are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not participate

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01522963
DA029689, R21DA029689
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michael Kotlyar, PharmD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP