Neuroimaging Studies of Practice and Smoking

NCT ID: NCT03080844

Last Updated: 2021-03-05

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

TERMINATED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-03-26

Brief Summary

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The purpose of this research study is to help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.

Detailed Description

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The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Primary investigator was blinded to intervention assignment

Study Groups

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Practice

Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks.

Group Type EXPERIMENTAL

Delay time to first cigarette

Intervention Type BEHAVIORAL

Participants asked to delay time until they smoke first cigarette of the day.

Therapy

Intervention Type BEHAVIORAL

Participants receive tips on how to resist the urge to smoke and control cravings to smoke.

No Practice

Participants will continue with their normal smoking behavior.

Group Type ACTIVE_COMPARATOR

Therapy

Intervention Type BEHAVIORAL

Participants receive tips on how to resist the urge to smoke and control cravings to smoke.

Interventions

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Delay time to first cigarette

Participants asked to delay time until they smoke first cigarette of the day.

Intervention Type BEHAVIORAL

Therapy

Participants receive tips on how to resist the urge to smoke and control cravings to smoke.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Smoke \> 10 cigarettes per day for the last 6 months
* Smokes first cigarette within 60 minutes after waking
* Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
* Willing to complete all appointments and change smoking behaviors for 2 weeks
* No quit attempts or attempts to cut back in the last 30 days
* No plans to quit in the next 30 days
* High school graduate or General Eduction Diploma (GED)

Exclusion Criteria

* Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment
* Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder
* Currently taking anti-seizure medication
* History of concussion
* Body mass index (BMI) over 50
* Left-handedness
* History of alcohol or other substance dependence or current abuse;
* Risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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Hoglund Brain Imaging Center, University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Fox AT, Catley D, Richter KP, Ellerbeck EF, Brucks MG, Papa VB, Martin LE. Functional brain activation changes associated with practice in delaying smoking among moderate to heavy smokers: study protocol and rationale of a randomized trial (COPE). Trials. 2018 Nov 12;19(1):623. doi: 10.1186/s13063-018-2984-x.

Reference Type DERIVED
PMID: 30419931 (View on PubMed)

Other Identifiers

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RSG-16-023-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00004095

Identifier Type: -

Identifier Source: org_study_id

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