Text Size

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

This study is currently recruiting participants.
Verified March 2013 by University of Minnesota - Clinical and Translational Science Institute
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: March 13, 2013
Last verified: March 2013
History of Changes
  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 4 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522963

Contacts
Contact: Anne Mills, MPH 612-624-9407 mill1752@umn.edu

Locations
United States, Minnesota
Clinical and Translational Sciences Institute Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Michael Kotlyar, PharmD            
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

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01522963     History of Changes
Other Study ID Numbers: DA029689, R21DA029689
Study First Received: January 17, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013