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Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01522963
First received: January 17, 2012
Last updated: June 8, 2017
Last verified: June 2017
January 17, 2012
June 8, 2017
December 2011
January 2014   (Final data collection date for primary outcome measure)
  • Craving [ Time Frame: 5 to 35 minutes ]
    The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.
  • Nicotine Withdrawal Symptoms [ Time Frame: 5 to 35 minutes ]
    The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.
Craving [ Time Frame: During the 1 hour period after exposure to stressful task ]
The craving increase that occurs when smokers are exposed to a stressful task will be measured
Complete list of historical versions of study NCT01522963 on ClinicalTrials.gov Archive Site
Not Provided
Nicotine withdrawal symptoms [ Time Frame: During the 1 hour period after exposure to stressful task ]
The increase in nicotine withdrawal symptoms that occurs when smokers are exposed to a stressful task will be measured
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
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Other
Tobacco Use Disorder
Drug: Nicotine lozenge
A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
  • Experimental: Nicotine Lozenge Immediately Prior to Stress task
    Subjects will receive the nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
    Intervention: Drug: Nicotine lozenge
  • Experimental: Nicotine lozenge 10 Minutes prior to Stress task
    Subjects will receive the nicotine lozenge after the stress task during one laboratory session and immediately prior to the stress task at the other laboratory session
    Intervention: Drug: Nicotine lozenge
  • Experimental: Nicotine lozenge 20 minutes prior to Stress task
    Subjects will receive the nicotine lozenge after the stress task during one laboratory session and 10 minutes prior to the stress task at the other laboratory session
    Intervention: Drug: Nicotine lozenge
  • Experimental: Nicotine Lozenge 30 minutes prior to stress taks
    Subjects will receive the nicotine lozenge 10 minutes prior to the stress task during one laboratory session and after the stress task at the other laboratory session
    Intervention: Drug: Nicotine lozenge
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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01522963
DA029689
R21DA029689 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
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
June 2017

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