Smoking Cessation Behavioral Treatment Study

Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE); Behavioral: Cognitive Behavioral Therapy (CBT)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madhura Athreya, MS; Phone Number: 5738822977; Email: athreyam@health.missouri.edu
• Study Contact Backup: Name: Brett Froeliger, PhD; Phone Number: 5738824785; Email: froeligerb@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri - Columbia
      • Contact: Brett Froeliger, PhD; Phone Number: 573-882-4785; Email: froeligerb@health.missouri.edu
      • Contact: Madhura Athreya, MS; Phone Number: 5738822799; Email: athreyam@health.missouri.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Medical University of South Carolina
      • Contact: Michael Saladin, PhD; Phone Number: 843-792-5306; Email: saladinm@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 2020602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No