Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Brett Froeliger, Medical University of South Carolina

Brief Summary:
The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) Behavioral: Cognitive Behavioral Therapy (CBT) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: MORE 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.




Primary Outcome Measures :
  1. Cigarette Smoking [ Time Frame: 7 weeks ]
    Biochemical smoking assessment (breath carbon monoxide) at each study visit.

  2. 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

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and up
  • English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks
  • Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
  • Current nicotine dependent smoker with a minimum smoking history of 2 years
  • Interest in quitting smoking

Exclusion Criteria:

  • Use of psychotropic (e.g. antiepileptic) medications in the past month
  • Positive urine drug screen
  • Presence of an untreated medical illness
  • Current or past psychosis
  • History of major neurological illness or head injury resulting in loss of consciousness
  • And contraindication to MRI, including claustrophobia
  • Among females, positive urine pregnancy test
  • Inability or unwillingness of subject to give informed consent

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Madhura Athreya, MS 8437921608 athreya@musc.edu
Contact: Brett Froeliger, PhD 8437926018 froelige@musc.edu

Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brett Froeliger, PhD    843-792-6018    froelige@musc.edu   
Contact: Madhura Athreya, MS    8437921608    athreya@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Layout table for additonal information
Responsible Party: Brett Froeliger, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03948893    
Other Study ID Numbers: 00086509
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders