Tobacco Use DisorderPhase 2NCT00060814
Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients
A Phase 2 study testing Combined intervention in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Combined intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160 7420
About this study
Official title: Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT 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.
Read the detailed description
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Combined intervention
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined interventionOther
300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling
| Study group | Role | What they receive |
|---|---|---|
| Combined Pharmacotherapy and Counseling | Experimental | 300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing Receives: Other: Combined intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral
Measured: 6 months
Secondary outcomes (1)
Number of cigarettes smoked per day
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2003 (estimated)
- Study startJun 2002
- Primary completionSep 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kimber Richter, Ph.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060814
- Sponsor's protocol ID
- NIDA-00450-2
- Other IDs
- K01-00450-2
- Status last verified
- Oct 2016
- First submitted
- 14 May 2003
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.
- ClinicalTrials.gov ID
- NCT00060814
- Acronym / sponsor ID
- NIDA-00450-2
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Sep 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 15 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Pharmacotherapy and Counseling | Experimental | Other: Combined intervention300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined intervention300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling | Other | Combined Pharmacotherapy and Counseling |
Primary outcome
Behavioral
Time frame: 6 months
1 secondary outcome
Number of cigarettes smoked per day
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimber Richter, Ph.D. principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined intervention in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.