Smoking Cessation Behavioral Treatment Study

Tobacco Use Disorder Clinical Trial

Official title:

Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948893
• Other study ID #: 2020602
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: University of Missouri-Columbia
• Contact: Madhura Athreya, MS
• Phone: 5738822977
• Email: athreyam[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Mindfulness-Oriented Recovery Enhancement (MORE)
MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.
• Cognitive Behavioral Therapy (CBT)
CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Missouri - Columbia	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette Smoking	Biochemical smoking assessment (breath carbon monoxide) at each study visit.	7 weeks
Primary	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
Primary	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