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NCT Number: NCT03948893

Smoking Cessation Behavioral Treatment Study

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.

Recruiting

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri - Columbia, Columbia, Missouri, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Oriented Recovery Enhancement (MORE)

Behavioral

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

Cognitive Behavioral Therapy (CBT)

Behavioral

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

Primary outcomes

  1. Cigarette Smoking

    Time frame: 7 weeks

    Biochemical smoking assessment (breath carbon monoxide) at each study visit.

  2. Magnitude of change in fMRI brain response to images

    Time frame: 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

  3. Magnitude of change in fMRI brain connectivity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Froeliger, PhD

CONTACT

[email protected]

5738824785

Madhura Athreya, MS

CONTACT

[email protected]

5738822977

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Medical University of South Carolina

Registry information

Official study title

Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 14, 2019
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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