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Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522963
First Posted: February 1, 2012
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition Intervention
Tobacco Use Disorder Drug: Nicotine lozenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Craving [ Time Frame: Baseline, 6 months ]
    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.


Enrollment: 98
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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
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 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
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 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
Drug: Nicotine lozenge
A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522963


Locations
United States, Minnesota
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Michael Kotlyar, PharmD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01522963     History of Changes
Other Study ID Numbers: DA029689
R21DA029689 ( U.S. NIH Grant/Contract )
First Submitted: January 17, 2012
First Posted: February 1, 2012
Results First Submitted: February 13, 2017
Results First Posted: July 11, 2017
Last Update Posted: August 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action