Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

• ClinicalTrials.gov Identifier: NCT01522963
• Recruitment Status: Completed
• First Posted: February 1, 2012
• Results First Posted: July 11, 2017
• Last Update Posted: August 21, 2017
• Sponsor: University of Minnesota
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Use Disorder	Drug: Nicotine lozenge	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
• Study Start Date: December 2011
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Nicotine lozenge; A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
Experimental: 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	Drug: Nicotine lozenge; A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
Experimental: 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	Drug: Nicotine lozenge; A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
Experimental: 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	Drug: Nicotine lozenge; A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Outcome Measures

Primary Outcome Measures :

1. Craving [ Time Frame: Baseline, 6 months ]
   The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.
2. Nicotine Withdrawal Symptoms [ Time Frame: 5 to 35 minutes ]
   The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Michael Kotlyar, PharmD; University of Minnesota

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01522963
• Other Study ID Numbers: DA029689; R21DA029689 ( U.S. NIH Grant/Contract )
• First Posted: February 1, 2012
• Results First Posted: July 11, 2017
• Last Update Posted: August 21, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance Withdrawal Syndrome; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action