Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Tobacco Use Disorder Clinical Trial

Official title:

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522963
• Other study ID #: DA029689
• Secondary ID: R21DA029689
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: July 30, 2014
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Nicotine lozenge 4 mg
A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving	The craving increase that occurs when smokers are exposed to a stressful task will be measured	During the 1 hour period after exposure to stressful task	No
Secondary	Nicotine withdrawal symptoms	The increase in nicotine withdrawal symptoms that occurs when smokers are exposed to a stressful task will be measured	During the 1 hour period after exposure to stressful task	No