Smoking Cessation Behavioral Treatment Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03948893|
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) Behavioral: Cognitive Behavioral Therapy (CBT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction|
|Actual Study Start Date :||December 19, 2019|
|Estimated Primary Completion Date :||July 31, 2024|
|Estimated Study Completion Date :||July 31, 2024|
Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.
|Active Comparator: CBT||
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.
- Cigarette Smoking [ Time Frame: 7 weeks ]Biochemical smoking assessment (breath carbon monoxide) at each study visit.
- Magnitude of change in fMRI brain response to images [ Time Frame: 7 weeks ]Measure the effects of MORE on fMRI BOLD response to images (change from baseline to end of study) while participants undergo functional magnetic resonance imaging
- Magnitude of change in fMRI brain connectivity [ Time Frame: 7 weeks ]Measure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948893
|Contact: Madhura Athreya, MSemail@example.com|
|Contact: Brett Froeliger, PhDfirstname.lastname@example.org|