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OpenTrials
Completed

NCT Number: NCT01522963

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Lozenge

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2012
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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