Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Nicotine lozenge

• Registration Number: NCT01522963
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2017-02-13
• Results First Submitted QC: 2017-06-08
• Status Verified: 2017-07
• Results First Posted: 2017-07-11
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Smoking an average of at least 10 cigarette per day
• General good health

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine Lozenge Immediately Prior to Stress task	Nicotine lozenge	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
Nicotine lozenge 10 Minutes prior to Stress task	Nicotine lozenge	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
Nicotine lozenge 20 minutes prior to Stress task	Nicotine lozenge	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
Nicotine Lozenge 30 minutes prior to stress taks	Nicotine lozenge	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

Primary Outcome Measures

Name	Time	Method
Craving	Baseline, 6 months	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	5 to 35 minutes	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.

Trial Locations

Locations (1)

Clinical and Translational Sciences Institute; 🇺🇸 Minneapolis, Minnesota, United States