Smoking CessationNCT01257490
Integrated Smoking Cessation Treatment for Low Income Community Corrections
A study testing counseling vs. advice in people with Smoking Cessation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study recruited cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12 weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of bupropion treatment and 4 sessions of intensive… Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- counseling vs. advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2014
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 19 years or older
- Enrolled in criminal justice community supervision (e.g., probation, parole, drug court, community corrections, etc)
- Smoking at least 5 cpd for the past year
- Maintained in an unrestricted environment (e.g., not currently in a correctional facility or treatment facility) living in the Birmingham Area and surrounding communities
Who cannot join
- Pregnant or nursing (all women in this study will be required to use an acceptable form of contraception throughout the administration of the medication)
- Known sensitivity to Zyban or Wellbutrin
- History of seizures
- Current or prior anorexia or bulimia
- Abrupt withdrawal from alcohol or benzodiazepines
- Moderate to severe kidney problems
- Moderate liver problems
- Cognitive impairment such that they cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study recruited cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12 weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The study was stratified on race such that equal proportions of African Americans and Caucasians were enrolled in the two study groups. It was hypothesized that smokers receiving intensive counseling will have higher quit rates compared to smokers receiving brief advice to quit.
- Conditions
- Smoking Cessation
- Being tested
- counseling vs. advice
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling vs. adviceBehavioural
Also called counseling, wellbutrin, bupropion, zyban
1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Intensive counseling | Experimental | 4 sessions of intensive counseling plus bupropion Receives: Behavioral: counseling vs. advice |
| Brief Counseling | Active comparator | Brief physician advice to quit plus bupropion Receives: Behavioral: counseling vs. advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking cessation
Measured: 3 months
smoking cessation
Measured: 6 Month
smoking cessation
Measured: 9 Month
smoking cessation
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Karen Cropsey, University of Alabama at Birmingham
- Investigators
- Karen L Cropsey, Psy.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257490
- Sponsor's protocol ID
- R01CA141663
- Other IDs
- R01CA141663
- Status last verified
- Apr 2017
- First submitted
- 28 Oct 2010
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Smoking Cessation Treatment for Low Income Community Corrections
- ClinicalTrials.gov ID
- NCT01257490
- Acronym / sponsor ID
- R01CA141663
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Dec 2010 (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.
This study recruited cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12 weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The study was stratified on race such that equal proportions of African Americans and Caucasians were enrolled in the two study groups. It was hypothesized that smokers receiving intensive counseling will have higher quit rates compared to smokers receiving brief advice to quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive counseling | Experimental | Behavioral: counseling vs. advice4 sessions of intensive counseling plus bupropion |
| Brief Counseling | Active comparator | Behavioral: counseling vs. adviceBrief physician advice to quit plus bupropion |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 19 years or older
- Enrolled in criminal justice community supervision (e.g., probation, parole, drug court, community corrections, etc)
- Smoking at least 5 cpd for the past year
- Maintained in an unrestricted environment (e.g., not currently in a correctional facility or treatment facility) living in the Birmingham Area and surrounding communities
Key exclusion criteria (8 listed)
- Pregnant or nursing (all women in this study will be required to use an acceptable form of contraception throughout the administration of the medication)
- Known sensitivity to Zyban or Wellbutrin
- History of seizures
- Current or prior anorexia or bulimia
- Abrupt withdrawal from alcohol or benzodiazepines
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 |
|---|---|---|
| counseling vs. adviceAlso: counseling, wellbutrin, bupropion, zyban1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks) | Behavioural | Brief Counseling, Intensive counseling |
Primary outcome
smoking cessation
Time frame: 3 months
smoking cessation
Time frame: 6 Month
smoking cessation
Time frame: 9 Month
smoking cessation
Time frame: 12 Month
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 18 Apr 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.
Karen L Cropsey, Psy.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling vs. advice in people with Smoking Cessation, run by University of Alabama at Birmingham 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 4 inclusion and 8 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 18 Apr 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.
What does the primary outcome measure?
smoking cessation (time frame: 3 months). The study lists 4 primary outcomes in all. 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 18 Apr 2017.