Tobacco Use DisorderNCT00051883
Chemical Dependency and Smoking Cessation: Patient's Views - 1
An observational study of Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to asses patient views on smoking cessation and tobacco harm reduction during drug treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Feb 2005
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Substance abuse treatment patients
Who may be able to join
- Selection criteria included being 18 years or older, smoking 5 or more cigarettes per day for at least 2 years, and being enrolled continuously in methadone maintenance treatment (MMT) for at least the past 2 years.
Who cannot join
- Being less than 18 years of age, smoking 4 or fewer cigarettes per day, smoking less than daily for less than 2 years, and not being enrolled continuously in methadone treatment for at least the 2 past years.
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: Chemical Dependency and Smoking Cessation: Patient's Views
The purpose of this study is to asses patient views on smoking cessation and tobacco harm reduction during drug treatment.
Read the detailed description
Participants included 34 patients who had never voluntarily quit smoking for longer than 24 hours (continuous smokers), 34 smokers who had quit smoking for at least 24 hours before but had relapsed (relapsers), and 10 former smokers who had been abstinent for at least the past 6 months (successful quitters). We held 7 focus groups, 3 with continuous smokers and 4 with relapsers. Focus groups lasted 2 hours and were held at participants' clinics to preserve confidentiality. We conducted hour-long individual interviews with successful quitters. All participants completed a brief written survey immediately before their session. Survey items included questions on demographics, smoking behaviors, and motivation for cessation, reduction, and nicotine maintenance. We reimbursed all participants $40 and provided a meal to focus group attendees.
- Conditions
- Tobacco Use Disorder
- Medical subject headings
- Tobacco Use Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2003 (estimated)
- Study startDec 1999
- Study completionFeb 2005
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 125 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
- NCT00051883
- Sponsor's protocol ID
- NIDA-00450-1
- Other IDs
- K01-00450-1
- Status last verified
- Oct 2016
- First submitted
- 17 Jan 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
- Chemical Dependency and Smoking Cessation: Patient's Views
- ClinicalTrials.gov ID
- NCT00051883
- Acronym / sponsor ID
- NIDA-00450-1
- Conditions
- Tobacco Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Dec 1999
- Study completion
- Feb 2005 (actual)
- First posted
- 20 Jan 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 study is to asses patient views on smoking cessation and tobacco harm reduction during drug treatment.
Detailed description
Participants included 34 patients who had never voluntarily quit smoking for longer than 24 hours (continuous smokers), 34 smokers who had quit smoking for at least 24 hours before but had relapsed (relapsers), and 10 former smokers who had been abstinent for at least the past 6 months (successful quitters). We held 7 focus groups, 3 with continuous smokers and 4 with relapsers. Focus groups lasted 2 hours and were held at participants' clinics to preserve confidentiality. We conducted hour-long individual interviews with successful quitters. All participants completed a brief written survey immediately before their session. Survey items included questions on demographics, smoking behaviors, and motivation for cessation, reduction, and nicotine maintenance. We reimbursed all participants $40 and provided a meal to focus group attendees.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Substance abuse treatment patients
Key inclusion criteria (1 listed)
- Selection criteria included being 18 years or older, smoking 5 or more cigarettes per day for at least 2 years, and being enrolled continuously in methadone maintenance treatment (MMT) for at least the past 2 years.
Key exclusion criteria (1 listed)
- Being less than 18 years of age, smoking 4 or fewer cigarettes per day, smoking less than daily for less than 2 years, and not being enrolled continuously in methadone treatment for at least the 2 past years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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?
An observational study of 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 1 inclusion and 1 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.
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.
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.