Smoking Cessation Behavioral Treatment Study

NCT ID: NCT03948893

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MORE

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement (MORE)

Intervention Type BEHAVIORAL

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

CBT

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-Oriented Recovery Enhancement (MORE)

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

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Brett Froeliger

Professor Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Missouri - Columbia

Columbia, Missouri, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Madhura Athreya, MS

Role: CONTACT

5738822977

Brett Froeliger, PhD

Role: CONTACT

5738824785

Facility Contacts

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Brett Froeliger, PhD

Role: primary

573-882-4785

Madhura Athreya, MS

Role: backup

5738822799

Michael Saladin, PhD

Role: primary

843-792-5306

Other Identifiers

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2020602

Identifier Type: -

Identifier Source: org_study_id

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