Bupropion as an Adjunct to the Nicotine Patch Plus CBT

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00142831
First received: September 1, 2005
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Drug: Pharmacotherapies for Smoking Cessation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis [ Time Frame: Weekly, and 13 weeks after beginning study medication (Week 13). ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: April 1999
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bupropion-SR, 150 mg/day x 3 days, then 300 mg/day for 13 weeks
Drug: Pharmacotherapies for Smoking Cessation
Bupropion-SR or Identical Placebo
Placebo Comparator: 2
Identical Placebo
Drug: Pharmacotherapies for Smoking Cessation
Bupropion-SR or Identical Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142831

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Investigators
Principal Investigator: Maurizio Fava, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Maurizio Fava, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00142831     History of Changes
Other Study ID Numbers: NIDA-11512-1, R01-11512-1, DPMC
Study First Received: September 1, 2005
Last Updated: August 21, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014