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Completed

NCT Number: NCT00060814

Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

Completed

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160 7420, United States

About this study

This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in long-term methadone maintenance treatment
  • Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months

Exclusion criteria

  • Patients who use prescription drug regimens that might affect methadone or bupropion metabolism
  • Patients with cardiovascular disease, asthma, COPD
  • Patients who are pregnant or breastfeeding
  • Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)

Treatment and study plan

Combined intervention

Other

300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling

Primary outcomes

  1. Behavioral

    Time frame: 6 months

Secondary outcomes

  1. Number of cigarettes smoked per day

    Time frame: six months

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
May 15, 2003
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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