Medicinal Nicotine for Preventing Cue Induced Craving

Tobacco Use Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347605
• Other study ID #: WS2385492
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: December 15, 2017
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Nicotine lozenge 4 mg

• Placebo lozenge

Locations

Country	Name	City	State
United States	Clinical and Translational Sciences Institute	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 15 minutes
Primary	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.	approximately 15 minutes