Smoking CessationCOPENCT03080844
Neuroimaging Studies of Practice and Smoking
A study testing Delay time to first cigarette and Therapy 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 help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Delay time to first cigarette and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 26 Mar 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smoke > 10 cigarettes per day for the last 6 months
- Smokes first cigarette within 60 minutes after waking
- Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
- Willing to complete all appointments and change smoking behaviors for 2 weeks
- No quit attempts or attempts to cut back in the last 30 days
- No plans to quit in the next 30 days
- High school graduate or General Eduction Diploma (GED)
Who cannot join
- Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment
- Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder
- Currently taking anti-seizure medication
- History of concussion
- Body mass index (BMI) over 50
- Left-handedness
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 and Brain Activation: How Practice Changes the Brain
The purpose of this research study is to help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.
Read the detailed description
The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.
- Conditions
- Smoking Cessation
- Being tested
- Delay time to first cigarette, Therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delay time to first cigaretteBehavioural
Participants asked to delay time until they smoke first cigarette of the day.
TherapyBehavioural
Participants receive tips on how to resist the urge to smoke and control cravings to smoke.
| Study group | Role | What they receive |
|---|---|---|
| Practice | Experimental | Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks. Receives: Behavioral: Delay time to first cigarette; Behavioral: Therapy |
| No Practice | Active comparator | Participants will continue with their normal smoking behavior. Receives: Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues
Change measured via functional magnetic resonance imaging (fMRI)
Measured: Baseline (Day 7) to End of Study (Day 22)
Secondary outcomes (1)
Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues
Change measured via functional magnetic resonance imaging (fMRI)
Measured: Baseline (Day 7) to End of Study (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startDec 2016
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Laura Martin, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080844
- Sponsor's protocol ID
- STUDY00004095
- Other IDs
- RSG-16-023-01
- Acronym
- COPE
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2017
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fox AT, Catley D, Richter KP, Ellerbeck EF, Brucks MG, Papa VB, Martin LE. Functional brain activation changes associated with practice in delaying smoking among moderate to heavy smokers: study protocol and rationale of a randomized trial (COPE). Trials. 2018 Nov 12;19(1):623. doi: 10.1186/s13063-018-2984-x.
PubMed 30419931
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation and Brain Activation: How Practice Changes the Brain
- ClinicalTrials.gov ID
- NCT03080844
- Acronym / sponsor ID
- COPE / STUDY00004095
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Dec 2016 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 15 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 help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.
Detailed description
The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice | Experimental | Behavioral: Delay time to first cigarette, Behavioral: TherapyParticipants will be asked to delay time to smoking first cigarette of the day for up to two weeks. |
| No Practice | Active comparator | Behavioral: TherapyParticipants will continue with their normal smoking behavior. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Smoke > 10 cigarettes per day for the last 6 months
- Smokes first cigarette within 60 minutes after waking
- Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
- Willing to complete all appointments and change smoking behaviors for 2 weeks
- No quit attempts or attempts to cut back in the last 30 days
Key exclusion criteria (9 listed)
- Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment
- Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder
- Currently taking anti-seizure medication
- History of concussion
- Body mass index (BMI) over 50
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 |
|---|---|---|
| Delay time to first cigaretteParticipants asked to delay time until they smoke first cigarette of the day. | Behavioural | Practice |
| TherapyParticipants receive tips on how to resist the urge to smoke and control cravings to smoke. | Behavioural | No Practice, Practice |
Primary outcome
Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues
Time frame: Baseline (Day 7) to End of Study (Day 22)
Change measured via functional magnetic resonance imaging (fMRI)
1 secondary outcome
Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues
Time frame: Baseline (Day 7) to End of Study (Day 22)
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 30419931Fox AT, Catley D, Richter KP, Ellerbeck EF, Brucks MG, Papa VB, Martin LE. Functional brain activation changes associated with practice in delaying smoking among moderate to heavy smokers: study protocol and rationale of a randomized trial (COPE). Trials. 2018 Nov 12;19(1):623. doi: 10.1186/s13063-018-2984-x.
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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 Delay time to first cigarette and Therapy 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 7 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: stopped early, as of the sponsor's last update on 5 Mar 2021. 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 was stopped early (reason given: COVID-19). 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?
Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues (time frame: Baseline (Day 7) to End of Study (Day 22)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080844, which also lists 1 linked publication.
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 5 Mar 2021.