Nicotine DependenceNCT01550029
Targeted Intervention for Bipolar Smokers
A study testing Counseling/Healthy Lifestyle and Counseling/Managing Mood in people with Nicotine Dependence and Bipolar Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence, Bipolar Disorder
- What is being tested?
- Counseling/Healthy Lifestyle and Counseling/Managing Mood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are motivated to quit smoking
- Male or female
- 18 years of age or older
- Diagnosed with bipolar disorder according to DSM-IV criteria
- Stable on medication with no significant changes in the last 3 months before enrollment.
- Smoking 10 cigarettes/day for the past 90 days
Who cannot join
- Healthy volunteers
- Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
- Not being and being treated with medication for the bipolar disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Cincinnati
Cincinnati, Ohio, 452219
About this study
The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.
Read the detailed description
All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.
- Conditions
- Nicotine Dependence, Bipolar Disorder
- Being tested
- Counseling/Healthy Lifestyle, Counseling/Managing Mood
- Keywords
- Smoking, Tobacco, Nicotine, Bipolar
- Medical subject headings
- Tobacco Use Disorder, Bipolar Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling/Healthy LifestyleBehavioural
Also called Behavior therapy
A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help develop knowledge and skills for quitting. Also, the National Cancer Institute's "Clearing the Air" guide to smoking cessation will be given to subjects. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways for establishing a healthier lifestyle.
Counseling/Managing MoodBehavioural
Also called Behavior Therapy
A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting.
| Study group | Role | What they receive |
|---|---|---|
| Counseling/Mood Management | Experimental | A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help you develop knowledge and skills that can help you quit. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting. Receives: Behavioral: Counseling/Managing Mood |
| Counseling/Healthy Lifestyle | Active comparator | A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways to establish a healthier lifestyle. Receives: Behavioral: Counseling/Healthy Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Abstinence from Smoking
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.
Measured: Last four weeks of treatment period
Secondary outcomes (1)
Prevalence of Abstinence from Smoking
Prevalence abstinence will be assessed during the last 7 days of treatment period, 7 days prior to follow-up visit.
Measured: Last 7 days of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJul 2010
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jaimee Heffner, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550029
- Sponsor's protocol ID
- 09-09-14-02
- Other IDs
- 1K23DA026517-01A1
- Status last verified
- Jan 2014
- First submitted
- 21 Apr 2011
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intervention for Bipolar Smokers
- ClinicalTrials.gov ID
- NCT01550029
- Acronym / sponsor ID
- 09-09-14-02
- Conditions
- Nicotine Dependence, Bipolar Disorder
- Keywords
- Smoking, Tobacco, Nicotine, Bipolar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2010
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 9 Mar 2012 (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 research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.
Detailed description
All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling/Mood Management | Experimental | Behavioral: Counseling/Managing MoodA trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help you develop knowledge and skills that can help you quit. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting. |
| Counseling/Healthy Lifestyle | Active comparator | Behavioral: Counseling/Healthy LifestyleA trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways to establish a healthier lifestyle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who are motivated to quit smoking
- Male or female
- 18 years of age or older
- Diagnosed with bipolar disorder according to DSM-IV criteria
- Stable on medication with no significant changes in the last 3 months before enrollment.
Key exclusion criteria (3 listed)
- Healthy volunteers
- Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
- Not being and being treated with medication for the bipolar disorder
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/Healthy LifestyleAlso: Behavior therapyA trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help develop knowledge and skills for quitting. Also, the National Cancer Institute's "Clearing the Air" guide to smoking cessation will be given to subjects. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways for establishing a healthier lifestyle. | Behavioural | Counseling/Healthy Lifestyle |
| Counseling/Managing MoodAlso: Behavior TherapyA trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's "Clearing the Air" guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting. | Behavioural | Counseling/Mood Management |
Primary outcome
Prolonged Abstinence from Smoking
Time frame: Last four weeks of treatment period
Confirmed prolonged abstinence from smoking during the last 4 weeks of the treatment period.
1 secondary outcome
Prevalence of Abstinence from Smoking
Time frame: Last 7 days of treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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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.
Jaimee Heffner, MD principal investigator
University of Cincinnati
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/Healthy Lifestyle and Counseling/Managing Mood in people with Nicotine Dependence and Bipolar Disorder, run by University of Cincinnati 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jan 2014. 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?
Results are not available in the source record.
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?
Prolonged Abstinence from Smoking (time frame: Last four weeks of treatment period). 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 7 Jan 2014.