Smoking Cessation Behavioral Treatment Study
Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedAugust 7, 2024
August 1, 2024
5.3 years
May 10, 2019
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Cigarette Smoking
Biochemical smoking assessment (breath carbon monoxide) at each study visit.
7 weeks
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
7 weeks
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.
7 weeks
Study Arms (2)
MORE
EXPERIMENTALCBT
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Missouri - Columbia
Columbia, Missouri, 65211, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Psychiatry
Study Record Dates
First Submitted
May 10, 2019
First Posted
May 14, 2019
Study Start
December 19, 2019
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share