Tobacco Use DisorderNCT03948893
Smoking Cessation Behavioral Treatment Study
A study testing Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT) in people with Tobacco Use Disorder, run by University of Missouri-Columbia at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2019to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Missouri - Columbia
Columbia, Missouri, 65211
About this study
Official title: Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Mindfulness-Oriented Recovery Enhancement (MORE), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Recovery Enhancement (MORE)Behavioural
MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.
Cognitive Behavioral Therapy (CBT)Behavioural
CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.
| Study group | Role | What they receive |
|---|---|---|
| MORE | Experimental | Not described Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) |
| CBT | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Smoking
Biochemical smoking assessment (breath carbon monoxide) at each study visit.
Measured: 7 weeks
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
Measured: 7 weeks
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start19 Dec 2019
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Principal investigator, Brett Froeliger, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948893
- Sponsor's protocol ID
- 2020602
- Status last verified
- Oct 2026
- First submitted
- 10 May 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction
- ClinicalTrials.gov ID
- NCT03948893
- Acronym / sponsor ID
- 2020602
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORE | Experimental | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) |
| CBT | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement (MORE)MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. | Behavioural | MORE |
| Cognitive Behavioral Therapy (CBT)CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors. | Behavioural | CBT |
Primary outcome
Cigarette Smoking
Time frame: 7 weeks
Biochemical smoking assessment (breath carbon monoxide) at each study visit.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
Tobacco Use Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT) in people with Tobacco Use Disorder, run by University of Missouri-Columbia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette Smoking (time frame: 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.