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Bupropion as an Adjunct to the Nicotine Patch Plus CBT

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pharmacotherapies for Smoking Cessation
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring nicotine dependence

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

Identical Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00142831
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
nicotine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bupropion-SR, 150 mg/day x 3 days, then 300 mg/day for 13 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Identical Placebo
Intervention Type
Drug
Intervention Name(s)
Pharmacotherapies for Smoking Cessation
Intervention Description
Bupropion-SR or Identical Placebo
Primary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Fava, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bupropion as an Adjunct to the Nicotine Patch Plus CBT

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