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
  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:


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


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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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: July 30, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014