Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

NCT ID: NCT01522963

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-01-31

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nicotine Lozenge Immediately Prior to Stress task

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

Group Type: EXPERIMENTAL

Nicotine lozenge

Intervention Type: DRUG

A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Nicotine lozenge 10 Minutes prior to Stress task

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

Group Type: EXPERIMENTAL

Nicotine lozenge

Intervention Type: DRUG

A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Nicotine lozenge 20 minutes prior to Stress task

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

Group Type: EXPERIMENTAL

Nicotine lozenge

Intervention Type: DRUG

A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Nicotine Lozenge 30 minutes prior to stress taks

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

Group Type: EXPERIMENTAL

Nicotine lozenge

Intervention Type: DRUG

A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Interventions

Nicotine lozenge

A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kotlyar, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28235705 (View on PubMed)

Other Identifiers

R21DA029689

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA029689

Identifier Type: -

Identifier Source: org_study_id