Clinical trial NCT03080844: Neuroimaging Studies of Practice and Smoking
Official title: Smoking Cessation and Brain Activation: How Practice Changes the Brain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-03-15
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues
timeFrame: Baseline (Day 7) to End of Study (Day 22)
Secondary outcomes:
measure: Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues
timeFrame: Baseline (Day 7) to End of Study (Day 22)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Hoglund Brain Imaging Center, University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Laura Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.