Back to resultsSmoking Cessation Behavioral Treatment Study
Primary Purpose
Tobacco Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement (MORE)
Cognitive Behavioral Therapy (CBT)
Sponsored by
About this trial
This is an interventional basic science trial for Tobacco Use Disorder
Eligibility 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
Sites / Locations
- University of Missouri - ColumbiaRecruiting
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MORE
CBT
Arm Description
Outcomes
Primary Outcome Measures
Cigarette Smoking
Biochemical smoking assessment (breath carbon monoxide) at each study visit.
Magnitude of change in fMRI brain response to images
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
Measure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.
Secondary Outcome Measures
Full Information
NCT ID
NCT03948893
First Posted
May 10, 2019
Last Updated
May 31, 2023
Sponsor
University of Missouri-Columbia
Collaborators
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03948893
Brief Title
Smoking Cessation Behavioral Treatment Study
Official Title
Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MORE
Arm Type
Experimental
Arm Title
CBT
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement (MORE)
Intervention Description
MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.
Primary Outcome Measure Information:
Title
Cigarette Smoking
Description
Biochemical smoking assessment (breath carbon monoxide) at each study visit.
Time Frame
7 weeks
Title
Magnitude of change in fMRI brain response to images
Description
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
Time Frame
7 weeks
Title
Magnitude of change in fMRI brain connectivity
Description
Measure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madhura Athreya, MS
Phone
5738822977
Email
athreyam@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Froeliger, PhD
Phone
5738824785
Email
froeligerb@health.missouri.edu
Facility Information:
Facility Name
University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Froeliger, PhD
Phone
573-882-4785
Email
froeligerb@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Madhura Athreya, MS
Phone
5738822799
Email
athreyam@health.missouri.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Saladin, PhD
Phone
843-792-5306
Email
saladinm@musc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smoking Cessation Behavioral Treatment Study
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