Back to resultsMedicinal Nicotine for Preventing Cue Induced Craving
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine lozenge 4 mg
Placebo lozenge
Sponsored by
About this trial
This is an interventional other trial for Tobacco Use Disorder
Eligibility 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
Sites / Locations
- Clinical and Translational Sciences Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Nicotine lozenge 4 mg prior to cue exposure
Placebo lozenge prior to cue exposure
Control condition: Lozenge after cue exposure
Arm Description
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Placebo lozenge is used 15 minutes prior to smoking cue exposure
Lozenge is used immediately after smoking cue exposure
Outcomes
Primary Outcome Measures
Craving Symptom Severity Score Assessed Via Questionnaire
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.
Withdrawal Symptom Severity Score Assessed Via Questionnaire
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02347605
First Posted
January 14, 2015
Last Updated
December 15, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02347605
Brief Title
Medicinal Nicotine for Preventing Cue Induced Craving
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine lozenge 4 mg prior to cue exposure
Arm Type
Experimental
Arm Description
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Arm Title
Placebo lozenge prior to cue exposure
Arm Type
Placebo Comparator
Arm Description
Placebo lozenge is used 15 minutes prior to smoking cue exposure
Arm Title
Control condition: Lozenge after cue exposure
Arm Type
Other
Arm Description
Lozenge is used immediately after smoking cue exposure
Intervention Type
Drug
Intervention Name(s)
Nicotine lozenge 4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo lozenge
Primary Outcome Measure Information:
Title
Craving Symptom Severity Score Assessed Via Questionnaire
Description
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.
Time Frame
approximately 15 minutes
Title
Withdrawal Symptom Severity Score Assessed Via Questionnaire
Description
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.
Time Frame
approximately 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kotlyar, PharmD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Sciences Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Medicinal Nicotine for Preventing Cue Induced Craving
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