Bupropion as an Adjunct to the Nicotine Patch Plus CBT

Status Completed

Clinical Trial Summary

Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.

Clinical Trial Description

Smoking cessation treatment is highly cost effective and pharmacotherapy is universally recommended for treatment of nicotine dependence. However, the majority of smokers are unable to quit even with treatment. Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. The purpose of this study is to examine the effectiveness of bupropion as an addition to a standard smoking cessation treatment of CBT and nicotine replacement. In addition, this study will determine if bupropion improves an individual's odds of quitting smoking, and whether this is achieved through its impact on negative mood states associated with depression.

Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. CBT sessions and individual meetings with a study physician will last for 13 weeks. Treatment with either bupropion or placebo will begin at the first CBT meeting and will continue for 13 weeks. Treatment with the nicotine replacement patch will begin at the second CBT meeting and will continue for 10 weeks. Participants will have monthly follow-up visits throughout the year following Week 13. During the follow-up period, participants will continue to take either bupropion or placebo but will no longer undergo CBT or nicotine replacement. If participants are unable to quit smoking, or become more depressed during the follow-up phase, they will be offered treatment with Zoloft, and will continue to be monitored for the duration of the follow-up year. If participants have been unsuccessful in using Zoloft, they will be offered another antidepressant at the judgement of the clinician. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Tobacco Use Disorder

Clinical Trial Details

NCT number	NCT00142831
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 4
Start date	April 1999
Completion date	August 2006

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	`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
Completed	`NCT01625767` - Tobacco Approach Avoidance Training for Adolescent Smokers-1	Phase 2
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	`NCT00158145` - Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2	Phase 2
Completed	`NCT00158158` - Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2	Phase 2/Phase 3
Completed	`NCT00134927` - A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches	N/A