Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use Disorder

Treatments: Drug: Nicotine lozenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01522963

DA029689

R21DA029689 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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98 participants in 4 patient groups

Nicotine Lozenge Immediately Prior to Stress task

Experimental group

Description:

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

Treatment:

Drug: Nicotine lozenge

Nicotine lozenge 10 Minutes prior to Stress task

Experimental group

Description:

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

Treatment:

Drug: Nicotine lozenge

Nicotine lozenge 20 minutes prior to Stress task

Experimental group

Description:

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

Treatment:

Drug: Nicotine lozenge

Nicotine Lozenge 30 minutes prior to stress taks

Experimental group

Description:

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

Treatment:

Drug: Nicotine lozenge