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Medicinal Nicotine for Preventing Cue Induced Craving

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.
 
ClinicalTrials.gov Identifier: NCT02347605
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
The purpose of this study is to determine if changing the timeframe (relative to cue presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In this cross-over study, all subjects attend three laboratory sessions at which either nicotine lozenge or placebo is given prior to presentation of smoking cues or after presentation of smoking cues. The order in which the three conditions will be presented are randomized.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Nicotine lozenge 4 mg Drug: Placebo lozenge Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Nicotine lozenge 4 mg prior to cue exposure
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
 Drug: Nicotine lozenge 4 mg
Placebo Comparator: Placebo lozenge prior to cue exposure
Placebo lozenge is used 15 minutes prior to smoking cue exposure
 Drug: Placebo lozenge
Control condition: Lozenge after cue exposure
Lozenge is used immediately after smoking cue exposure
 Drug: Nicotine lozenge 4 mg


Outcome Measures
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Primary Outcome Measures :
  1. Craving Symptom Severity Score Assessed Via Questionnaire [ Time Frame: approximately 15 minutes ]
    Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.

  2. Withdrawal Symptom Severity Score Assessed Via Questionnaire [ Time Frame: approximately 15 minutes ]
    Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoking a minimum number of cigarettes per day
  • General good health

Exclusion Criteria:

  • unstable medical or psychiatric conditions
  • history of severe motion sickness (due to virtual reality equipment used to present cues)
  • women who are pregnant or breast feeding

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

Contacts and Locations
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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): NCT02347605


Locations
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United States, Minnesota
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Michael Kotlyar, PharmD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02347605    
Other Study ID Numbers: WS2385492
First Posted: January 27, 2015    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Tobacco Use Disorder
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