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Completed

NCT Number: NCT00392379

Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

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Key information

Conditions

Smokeless Tobacco Use Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic, Rochester, Minnesota, United States

Loading trial locations.

About this study

Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • are at least 18 years of age;
  • report smokeless tobacco (ST) as their primary tobacco of use;
  • have used ST daily for the past 6 months;
  • are in general good health (determined by medical history and screening physical examination);
  • have been provided with, understand, and have signed the informed consent.

Treatment and study plan

Nicotine Lozenges

Drug

Nicotine lozenges, 4 mg

Other names: Commit nicotine lozenge

Placebo lozenge

Drug

Placebo lozenge

Primary outcomes

  1. Prolonged Smokeless Tobacco Abstinence at 3 Months

    Time frame: 3 months

    Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.

Secondary outcomes

  1. Self-reported Point Prevalence All Tobacco Abstinence at 3 Months

    Time frame: 3 months

    Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.

  2. Prolonged Smokeless Tobacco Abstinence at 6 Months

    Time frame: 6 months

    Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 26, 2006
Registry last updated
Apr 24, 2013

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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