Clinical Trials Logo
  1. Home
  2. Tobacco Use Disorder
  3. NCT00218244

Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use — Brandswitch  

Tobacco Use Disorder Clinical Trial

Official title:
Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use

Clinical Trial Summary

Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Clinical Trial Description

Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00218244
Study type Interventional
Source National Institute on Drug Abuse (NIDA)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 2001
Completion date November 2004
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 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
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
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 NCT00158145 - Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2 Phase 2
Completed NCT01213524 - Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia Phase 2