Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Maintenance Treatment for Abstinent Smokers

This study has been completed.
Research Foundation for Mental Hygiene, Inc.
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: June 25, 2003
Last updated: January 5, 2010
Last verified: January 2010

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:

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.


Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00063323

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Principal Investigator: Lirio S. S Covey, Ph.D. Research Foundation for Mental Hygiene, Inc.
  More Information

Responsible Party: Lirio S. Covey, Research Foundation for Mental Hygiene 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
Nicotine replacement

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Antidepressive Agents
Antidepressive Agents, Second-Generation
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses processed this record on November 25, 2014