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Smoking Cessation Behavioral Treatment Study

Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03948893
Enrollment
200
Registered
2019-05-14
Start date
2019-12-19
Completion date
2025-03-31
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

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.

Interventions

MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.

BEHAVIORALCognitive Behavioral Therapy (CBT)

CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

Sponsors

Medical University of South Carolina
CollaboratorOTHER
University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cigarette Smoking7 weeksBiochemical smoking assessment (breath carbon monoxide) at each study visit.
Magnitude of change in fMRI brain response to images7 weeksMeasure 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 connectivity7 weeksMeasure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging.

Countries

United States

Contacts

Primary ContactMadhura Athreya, MS
athreyam@health.missouri.edu5738822977
Backup ContactBrett Froeliger, PhD
froeligerb@health.missouri.edu5738824785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026