Smoking CessationNCT03085602
Neuroimaging Studies of Smoking and Treatment
A study testing Cognitive behavioral therapy and Health education in people with Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Cognitive behavioral therapy and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 1 Feb 2019
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- smoke > 10 cigarettes per day
- vision is normal or corrected-to-normal
Who cannot join
- serious medical illness unsuitable for the MR scanner based on best clinical judgment
- any neurologic or psychiatric disorder
- diabetes
- known heart disease
- high blood pressure
- currently taking psychotropic or cardiovascular medication
Show all 9Show fewer
- history of alcohol or other substance dependence or current abuse
- risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoglund Brain Imaging Center, University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study
The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.
- Conditions
- Smoking Cessation
- Being tested
- Cognitive behavioral therapy, Health education
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Also called CBT
Therapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day.
Health educationBehavioural
Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.
| Study group | Role | What they receive |
|---|---|---|
| CBT Treatment | Experimental | Participants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments. Receives: Behavioral: Cognitive behavioral therapy |
| Control Group | Active comparator | Participants receive health education treatment. Participants will attend treatment sessions that match the CBT Treatment arm with respect to time and contact. Receives: Behavioral: Health education |
| Control Group - Scans | No intervention | Participants in this new arm to the study will receive no intervention and will receive three scans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activation in reward processing regions of the brain
Measured: Change from Baseline to Week 4
Secondary outcomes (2)
Change in activation in cognitive control regions of the brain
Measured: Change from Baseline to Week 4
Change in connectivity between reward and cognitive control regions of the brain
Measured: Change from Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startDec 2014
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
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 Kansas Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Martin, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085602
- Sponsor's protocol ID
- STUDY00001782
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study
- ClinicalTrials.gov ID
- NCT03085602
- Acronym / sponsor ID
- STUDY00001782
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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 study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT Treatment | Experimental | Behavioral: Cognitive behavioral therapyParticipants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments. |
| Control Group | Active comparator | Behavioral: Health educationParticipants receive health education treatment. Participants will attend treatment sessions that match the CBT Treatment arm with respect to time and contact. |
| Control Group - Scans | No intervention | –Participants in this new arm to the study will receive no intervention and will receive three scans. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- smoke > 10 cigarettes per day
- vision is normal or corrected-to-normal
Key exclusion criteria (9 listed)
- serious medical illness unsuitable for the MR scanner based on best clinical judgment
- any neurologic or psychiatric disorder
- diabetes
- known heart disease
- high blood pressure
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 |
|---|---|---|
| Cognitive behavioral therapyAlso: CBTTherapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day. | Behavioural | CBT Treatment |
| Health educationTherapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual. | Behavioural | Control Group |
Primary outcome
Change in activation in reward processing regions of the brain
Time frame: Change from Baseline to Week 4
2 secondary outcomes
Change in activation in cognitive control regions of the brain
Time frame: Change from Baseline to Week 4
Change in connectivity between reward and cognitive control regions of the brain
Time frame: Change from Baseline to Week 4
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 16 Apr 2019.
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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.
Laura Martin, PhD 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 study testing Cognitive behavioral therapy and Health education in people with Smoking Cessation, run by University of Kansas Medical Center 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 9 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 16 Apr 2019. 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?
Change in activation in reward processing regions of the brain (time frame: Change from Baseline to Week 4). 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 16 Apr 2019.