Maintenance Treatment for Abstinent Smokers

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Tobacco Use Disorder

Treatments: Drug: Bupropion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00063323

NIDA-13490-1

R01DA013490 (U.S. NIH Grant/Contract)

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 589 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

589 participants in 4 patient groups, including a placebo group

Bupropion

Active Comparator group

Description:

Bupropion (brand name Zyban Sustained Release). Participants used bupropion SR 150 mg twice daily during the 16-week maintenance treatment.

Treatment:

Drug: Bupropion

Nicotine gum

Active Comparator group

Description:

Nicotine gum (brand name Nicorette) During the maintenance 16-week maintenance treatment phase, participants assigned to this arm received 2 mg. nicotine gum.

Treatment:

Drug: Bupropion

Bupropion+Nicotine Gum

Active Comparator group

Description:

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.

Treatment:

Drug: Bupropion

Double placebo

Placebo Comparator group

Description:

Placebo gum + placebo pill. Identical placebo pill was used twice daily and identical placebo gum was used as needed.

Treatment:

Drug: Bupropion