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Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

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Mass General Brigham

Status and phase

Terminated
Phase 4

Conditions

Nicotine Dependence
Schizophrenia

Treatments

Drug: Bupropion SR 150mg bid
Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy
Drug: NRT

Study type

Interventional

Funder types

Other

Identifiers

NCT01576640
P2008-04

Details and patient eligibility

About

After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
  • Reported smoking 10 or more cigarettes per day for at least the prior year
  • Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
  • Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
  • Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment

Exclusion criteria

  • Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Replapse Prevention Therapy
Other group
Treatment:
Drug: Bupropion SR 150mg bid
Drug: NRT
Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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