Expired Study
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Boston, Massachusetts 02114


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.


Study summary:

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.


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


Study is Available At:


Original ID:

NIDA-11512-1


NCT ID:

NCT00142831


Secondary ID:

R01-11512-1


Study Acronym:


Brief Title:

Bupropion as an Adjunct to the Nicotine Patch Plus CBT


Official Title:

Effectiveness of Bupropion Used in Combination With the Nicotine Replacement Patch and Cognitive Behavioral Therapy for Treating Nicotine Dependent Individuals - 1


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

293


Enrollment Type:

Actual


Overall Contact Information

Official Name:Maurizio Fava, M.D.
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:April 1999
Completion Date:August 2006
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:August 2008
Last Changed Date:January 11, 2017
First Received Date:September 1, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure: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).
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pharmacotherapies for Smoking Cessation
Description:Bupropion-SR or Identical Placebo
Arm Name:1

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Identical Placebo
Study Arm Type:Experimental
Arm Name:1
Description:Bupropion-SR, 150 mg/day x 3 days, then 300 mg/day for 13 weeks

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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