Nicotine Lozenge to Reduce Smokeless Tobacco Use

NCT00218283 | Completed Phase 2 DMC

• 3 other identifiers: NIDA-14404-3R01-14404-3DPMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While there are many treatment programs that focus on stopping tobacco use, there are no interventions that specifically focus on reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing tobacco use in ST users.

Conditions

Tobacco Use Disorder

Keywords

Nicotine Dependence; Tobacco Dependence

Outcome Measures

Primary Outcomes (4)

• Reduction in tobacco use (measured by tobacco daily diary at Week 8, and the 12- and 26-week follow-up evaluations)

  8, 12 and 26 weeks

• Toxicity profile of carcinogen metabolites (measured by urine screens at Week 8, and the 12- and 26-week follow-up evaluations)

  8, 12 and 26 weeks

• Number of unsuccessful attempts to quit using tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations)

  8, 12 and 26 weeks

• Abstinence from tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations)

  8, 12 and 26 weeks

Secondary Outcomes (1)

• Motivation and self-efficacy (measured by a questionnaire at Week 8, and the 12- and 26-week follow-up evaluations)

  8, 12 and 26 weeks

Study Arms (2)

1 - Nicotine Lozenge

EXPERIMENTAL

Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date.

Drug: Nicotine Lozenge

2 Behavioral counseling

PLACEBO COMPARATOR

Use of behavioral counseling alone to help reduce tobacco use prior to quit date.

Behavioral: Behavioral Counseling

Interventions

Nicotine Lozenge DRUG

Oral Nicotine replacement product

Also known as: Commite Nicotine lozenge

1 - Nicotine Lozenge

Behavioral Counseling BEHAVIORAL

Use of behavioral counseling to reduce tobacco use.

2 Behavioral counseling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No interest in stopping ST use within 90 days of study entry
• Using ST at least 6 times a day in the 6 months prior to study entry
• Willing to use contraception throughout the study

You may not qualify if:

• Current use of tobacco or nicotine products, other than ST
• Current unstable medical condition
• Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
• Meets DSM-IV diagnostic criteria for any psychiatric disorder or substance abuse disorder within 6 months of study entry
• Use of any psychotropic medication within 6 months of study entry
• Pregnant or breastfeeding

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• University of Minnesota: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dorothy Hatsukami, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 10, 2017

Record last verified: 2008-06

Locations

US (1)