Maintenance Treatment for Abstinent Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00063323
Recruitment Status : Completed
First Posted : July 1, 2003
Last Update Posted : January 12, 2017
Research Foundation for Mental Hygiene, Inc.
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Bupropion Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 589 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintenance Treatment for Prevention of Smoking Relapse
Study Start Date : August 2000
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Survival abstinence rate with maintenance treatment [ Time Frame: 48 weeks after start of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00063323

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, Inc.
Principal Investigator: Lirio S. S Covey, Ph.D. Research Foundation for Mental Hygiene, Inc.

Publications of Results:
Responsible Party: Lirio S. Covey, Research Foundation for Mental Hygiene Identifier: NCT00063323     History of Changes
Other Study ID Numbers: NIDA-13490-1
R01DA013490 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: July 1, 2003    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2010

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors