Smoking Cessation Behavioral Treatment Study

Not Applicable

Recruiting

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE); Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT03948893
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Study Start: 2019-12-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MORE	Mindfulness-Oriented Recovery Enhancement (MORE)	-
CBT	Cognitive Behavioral Therapy (CBT)	-

Primary Outcome Measures

Name	Time	Method
Magnitude of change in fMRI brain response to images	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	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.
Cigarette Smoking	7 weeks	Biochemical smoking assessment (breath carbon monoxide) at each study visit.

Trial Locations

Locations (2)

University of Missouri - Columbia; 🇺🇸 Columbia, Missouri, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States