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Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine lozenge
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Translational Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Nicotine Lozenge Immediately Prior to Stress task

Nicotine lozenge 10 Minutes prior to Stress task

Nicotine lozenge 20 minutes prior to Stress task

Nicotine Lozenge 30 minutes prior to stress taks

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Craving
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2012
Last Updated
July 20, 2017
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01522963
Brief Title
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
Official Title
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine Lozenge Immediately Prior to Stress task
Arm Type
Experimental
Arm Description
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
Arm Title
Nicotine lozenge 10 Minutes prior to Stress task
Arm Type
Experimental
Arm Description
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
Arm Title
Nicotine lozenge 20 minutes prior to Stress task
Arm Type
Experimental
Arm Description
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
Arm Title
Nicotine Lozenge 30 minutes prior to stress taks
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nicotine lozenge
Intervention Description
A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
Primary Outcome Measure Information:
Title
Craving
Description
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.
Time Frame
Baseline, 6 months
Title
Nicotine Withdrawal Symptoms
Description
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.
Time Frame
5 to 35 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
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

Citations:
PubMed Identifier
28235705
Citation
Kotlyar M, Lindgren BR, Vuchetich JP, Le C, Mills AM, Amiot E, Hatsukami DK. Timing of nicotine lozenge administration to minimize trigger induced craving and withdrawal symptoms. Addict Behav. 2017 Aug;71:18-24. doi: 10.1016/j.addbeh.2017.02.018. Epub 2017 Feb 10.
Results Reference
derived

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Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

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