Nicotine Lozenge to Reduce Smokeless Tobacco Use

Status Completed

Clinical Trial 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.

Clinical Trial Description

Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. The need exists for a program specifically aimed towards reducing, rather than quitting, tobacco use. The purpose of this study is to evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the motivation to either quit or sustain lower levels of ST use.

This 8-week study will enroll frequent users of ST. Participants will be randomly assigned to receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone. All participants will be asked to alternate use of their usual ST brand with nicotine lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the following 4 weeks. Participants will be required to maintain a daily tobacco use diary. Study visits will occur once a week. Tobacco levels will be monitored with urine tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations will occur 12 and 26 weeks following the end of treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Tobacco Use Disorder

Clinical Trial Details

NCT number	NCT00218283
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 2
Start date	January 2005
Completion date	June 2007

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02432066` - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions	Phase 2
Completed	`NCT03960138` - Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Completed	`NCT04646668` - Comparative Abuse Liability Among African American and White Smokers	N/A
Completed	`NCT02560324` - Effect of Ramelteon on Smoking Abstinence	Phase 2
Completed	`NCT02347605` - Medicinal Nicotine for Preventing Cue Induced Craving	N/A
Completed	`NCT01570595` - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV	Phase 1/Phase 2
Completed	`NCT01625767` - Tobacco Approach Avoidance Training for Adolescent Smokers-1	Phase 2
Completed	`NCT01442753` - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth	N/A
Completed	`NCT01428310` - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke	Phase 1
Terminated	`NCT01800500` - Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers	N/A
Active, not recruiting	`NCT01539525` - Screening to Augment Referral to Treatment- Project START	Phase 2
Completed	`NCT00967005` - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers	Phase 2
Completed	`NCT01337817` - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers	Phase 1
Active, not recruiting	`NCT00751660` - Screening Methods in Finding Lung Cancer Early in Current or Former Smokers	N/A
Completed	`NCT00790569` - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking	N/A
Completed	`NCT00664261` - Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking	N/A
Completed	`NCT00134927` - A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches	N/A
Completed	`NCT00158158` - Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2	Phase 2/Phase 3
Completed	`NCT00158145` - Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2	Phase 2