Innovative Interventions for Smoking Cessation

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

Clinical Trial Description

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;

2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and

3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;

2. Nicotine patch for 6 weeks; or

3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored. ;

Study Design

Related Conditions & MeSH terms

Tobacco Use Disorder

Clinical Trial Details

NCT number	NCT01050569
Study type	Interventional
Source	University of Minnesota
Contact
Status	Completed
Phase	Phase 2
Start date	October 2008
Completion date	June 2012

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Withdrawn	`NCT02432066` - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions	Phase 2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	`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
Completed	`NCT01570595` - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV	Phase 1/Phase 2
Active, not recruiting	`NCT01539525` - Screening to Augment Referral to Treatment- Project START	Phase 2
Completed	`NCT01337817` - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers	Phase 1
Completed	`NCT00967005` - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers	Phase 2
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	`NCT01213524` - Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia	Phase 2
Completed	`NCT00218179` - Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1	N/A
Completed	`NCT00158145` - Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2	Phase 2