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Recruiting NCT03948893

Smoking Cessation Behavioral Treatment Study

No phase Interventional Tobacco Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Oriented Recovery Enhancement (MORE), Cognitive Behavioral Therapy (CBT).
Who it may be relevant to
Registry conditions: Tobacco Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

Overview

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

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

Primary outcome measures

  • Cigarette Smoking [Time frame: 7 weeks]
  • Magnitude of change in fMRI brain response to images [Time frame: 7 weeks]
  • Magnitude of change in fMRI brain connectivity [Time frame: 7 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • University of Missouri - Columbia — Columbia
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT03948893 · 2020602

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗