Bupropion as an Adjunct to the Nicotine Patch Plus CBT

NCT ID: NCT00142831

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2006-08-31

Brief 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.

Detailed 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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Bupropion-SR, 150 mg/day x 3 days, then 300 mg/day for 13 weeks

Group Type: EXPERIMENTAL

Pharmacotherapies for Smoking Cessation

Intervention Type: DRUG

Bupropion-SR or Identical Placebo

2

Identical Placebo

Group Type: PLACEBO_COMPARATOR

Pharmacotherapies for Smoking Cessation

Intervention Type: DRUG

Bupropion-SR or Identical Placebo

Interventions

Pharmacotherapies for Smoking Cessation

Bupropion-SR or Identical Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Smokes at least 10 cigarettes per day for at least the past 2 years
• Meets DSM-IV criteria for nicotine dependence, as determined by the Fagerstrom Nicotine Tolerance Questionnaire
• Meets DSM-IV diagnoses of unipolar depressive disorders (major depression, dysthymia, and minor depression)

Exclusion Criteria

• Current suicidal or homicidal risk
• Serious illness, including cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or hematologic disease
• Untreated peptic ulcer
• Life-threatening arrhythmia, cerebrovascular, or cardiovascular event within the 6 months prior to enrollment
• Severe respiratory compromise, as defined as a FEV-1 less than 1.0 L/min and/or pO2 less than 60 or pCO2 less than 45
• Currently using nicotine-containing products (e.g., cigar, pipe, snuff, nicotine gum)
• History of a seizure disorder
• Current DSM-IV diagnosis of organic mental disorder, schizophrenia, delusional disorder, psychotic disorder, bipolar disorder, or antisocial personality disorder
• Current DSM-IV diagnosis of substance abuse or dependence disorders within the year prior to enrollment
• Current eating disorder, including anorexia nervosa and bulimia nervosa
• History of multiple adverse drug reactions or allergy to bupropion
• Mood congruent or mood incongruent psychotic features
• Current use of other psychotropic drugs (with the exception of hypnotics and benzodiazepines at stable doses for at least six months prior to enrollment or current use of nonbenzodiazepine hypnotics such as Ambien and Sonata)
• Clinical or laboratory evidence of hypothyroidism
• Currently seeking treatment for smoking cessation
• History of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, or tapes
• Currently using topical drugs
• Pregnant
• Not using adequate methods of contraception

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Maurizio Fava, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type: DERIVED

PMID: 37230961 (View on PubMed)

Other Identifiers

R01-11512-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-11512-1

Identifier Type: -

Identifier Source: org_study_id