NCT03080844

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

3.3 years

First QC Date

February 17, 2017

Last Update Submit

March 2, 2021

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues

    Change measured via functional magnetic resonance imaging (fMRI)

    Baseline (Day 7) to End of Study (Day 22)

Secondary Outcomes (1)

  • Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues

    Baseline (Day 7) to End of Study (Day 22)

Study Arms (2)

Practice

EXPERIMENTAL

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

Behavioral: Delay time to first cigaretteBehavioral: Therapy

No Practice

ACTIVE COMPARATOR

Participants will continue with their normal smoking behavior.

Behavioral: Therapy

Interventions

Delay time to first cigaretteBEHAVIORAL

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

Practice
TherapyBEHAVIORAL

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

No PracticePractice

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoglund Brain Imaging Center, University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

    PMID: 30419931DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Laura Martin, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Primary investigator was blinded to intervention assignment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 15, 2017

Study Start

December 1, 2016

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

US(1)