NCT00142831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

Enrollment Period

7.3 years

First QC Date

September 1, 2005

Last Update Submit

January 11, 2017

Conditions

Tobacco Use Disorder

Keywords

nicotine dependence

Outcome Measures

Primary Outcomes (1)

  • 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis

    Weekly, and 13 weeks after beginning study medication (Week 13).

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Pharmacotherapies for Smoking Cessation

2

PLACEBO COMPARATOR

Identical Placebo

Drug: Pharmacotherapies for Smoking Cessation

Interventions

Pharmacotherapies for Smoking CessationDRUG

Bupropion-SR or Identical Placebo

12

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 37230961DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Maurizio Fava, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

April 1, 1999

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(1)