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Maintenance Treatment for Abstinent Smokers

This study has been completed.
Sponsor:
Collaborator:
Research Foundation for Mental Hygiene
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00063323
First received: June 25, 2003
Last updated: January 5, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.


Condition Intervention Phase
Tobacco Use Disorder
 Drug: Bupropion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintenance Treatment for Prevention of Smoking Relapse

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

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

Primary Outcome Measures:
  • Survival abstinence rate with maintenance treatment [ Time Frame: 48 weeks after start of treatment ] [ Designated as safety issue: No ]

Enrollment: 589
Study Start Date: August 2000
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion
Bupropion (brand name Zyban Sustained Release). Participants used bupropion SR 150 mg twice daily during the 16-week maintenance treatment.
 Drug: Bupropion
Active Comparator: Nicotine gum
Nicotine gum (brand name Nicorette) During the maintenance 16-week maintenance treatment phase, participants assigned to this arm received 2 mg. nicotine gum.
 Drug: Bupropion
Active Comparator: Bupropion+Nicotine Gum
Combined active treatments: Bupropion (Zyban SR) and nicotine gum (Nicorette). Participants were instructed to use the 150 mg bupropion pill twice daily and the 2 mg. gum as needed during the 16-week maintenance treatment phase.
 Drug: Bupropion
Placebo Comparator: Double placebo
Placebo gum + placebo pill. Identical placebo pill was used twice daily and identical placebo gum was used as needed.
 Drug: Bupropion

Detailed Description:

The goal of this study was to assess relapse prevention outcomes among individuals able to stop smoking when pharmacotherapy is extended beyond the standard duration of treatment. We hypothesized that maintenance treatment with prolonged bupropion use and/or "as needed" use of nicotine gum will reduce relapse to smoking. Participants were recruited through advertisements on radio, television, newspapers, the Internet, and various community outlets. Respondents were pre-screened by telephone using a standard interview. The first participant entered the OLT phase in February 2001; the final NTFU visit took place in October 2005.

The study was multi-phased consisting of: 1) eight-week open-label treatment (OLT) with bupropion and nicotine patch; 2) randomized double-blind assignment of OLT successes to 16 weeks of placebo-controlled maintenance treatment (MT); and 3) 24 weeks of non-treatment follow-up (NTFU). Participants received $25 compensation for completing the NTFU visits at Weeks 36 and 48. The Institutional Review Board of the New York State Psychiatric Institute approved the study. The study was performed at the Columbia University Medical Center Smoking Cessation Clinic in New York City.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who smoke at least 10 cigarettes daily and have attempted to quit smoking at least once

Exclusion Criteria:

  • Seizure History
  • Unstable Blood Pressure
  • Current major depression
  • Current alcohol/drug abuse or dependency
  • Lifetime psychotic illness
  • Current use of psychotropic drugs
  • Unstable medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063323

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Research Foundation for Mental Hygiene
Investigators
Principal Investigator: Lirio S. S Covey, Ph.D. Research Foundation for Mental Hygiene, Inc.
  More Information

Publications:

Responsible Party: Lirio S. Covey, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier: NCT00063323     History of Changes
Other Study ID Numbers: NIDA-13490-1, R01DA013490, DPMC
Study First Received: June 25, 2003
Last Updated: January 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Maintenance treatment
Smoking relapse
Bupropion
Nicotine replacement

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 May 23, 2013