Medicinal Nicotine for Preventing Cue Induced Craving

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Nicotine lozenge 4 mg; Drug: Placebo lozenge

• Registration Number: NCT02347605
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-27
• Results First Submitted: 2017-06-08
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-15
• Last Update Submitted: 2017-12-15
• Results First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine lozenge 4 mg prior to cue exposure	Nicotine lozenge 4 mg	Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Placebo lozenge prior to cue exposure	Placebo lozenge	Placebo lozenge is used 15 minutes prior to smoking cue exposure
Control condition: Lozenge after cue exposure	Nicotine lozenge 4 mg	Lozenge is used immediately after smoking cue exposure

Primary Outcome Measures

Name	Time	Method
Craving Symptom Severity Score Assessed Via Questionnaire	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.
Withdrawal Symptom Severity Score Assessed Via Questionnaire	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.

Trial Locations

Locations (1)

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