NCT00060814

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2003

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

May 14, 2003

Last Update Submit

January 11, 2017

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Behavioral

    6 months

Secondary Outcomes (1)

  • Number of cigarettes smoked per day

    six months

Study Arms (1)

Combined Pharmacotherapy and Counseling

EXPERIMENTAL

300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing

Other: Combined intervention

Interventions

Combined interventionOTHER

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

Combined Pharmacotherapy and Counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160 7420, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kimber Richter, Ph.D.

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

May 14, 2003

First Posted

May 15, 2003

Study Start

June 1, 2002

Primary Completion

September 1, 2002

Study Completion

December 1, 2002

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)