NCT01458834

Brief Summary

Several studies indicate that cigarette smokers show an attentional bias for cigarette-related cues, meaning that they more quickly detect and attend to and have more difficulty disengaging in cigarette-related information than neutral information. This bias is associated with craving and relapse following attempts to quit. This experiment will examine whether a computerized attentional training procedure will successfully reduce attentional bias towards smoking cues and reduce craving in regular cigarette smokers. The attentional training will be administered in a novel format in which participants complete 5-minute long training sessions 3 times per day and can complete the trainings via home computer or handheld device such as the iPhone, Android phone, or iPod touch. A baseline assessment in the laboratory will measure attentional bias to smoking cues and craving following smoking cue exposure. Participants will then be randomly assigned to either the active training condition or a control condition. In both conditions, participants will be asked to complete brief training sessions 3 times daily for one week using their personal computer or handheld device. Following one week of training, participants will return to the lab for endpoint assessment of attentional bias and craving. The investigators hypothesize that compared to the control condition, the active training condition will significantly reduce attentional bias toward smoking related cues and cue-induced cigarette craving.

Trial Health

55
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

10 months

First QC Date

October 22, 2011

Last Update Submit

October 22, 2011

Conditions

Smoking

Keywords

SmokingAttentional biasCraving

Outcome Measures

Primary Outcomes (2)

  • Brief Questionnaire of Smoking Urges (QSU-Brief)

    Assessed at baseline and endpoint visits (one week apart)

  • Attentional Bias Scores

    Assessed at baseline and endpoint visits (one week apart)

Study Arms (2)

Active attention training condition

EXPERIMENTAL
Behavioral: Attention bias modification task

Control condition

PLACEBO COMPARATOR
Behavioral: Control Condition

Interventions

Attention bias modification taskBEHAVIORAL

Participants will complete a computerized probe-discrimination task from their home computer or handheld electronic device 3 times per day for one week. Each training session will consist of 160 trials. In each trial, two pictures (smoking-related or neutral) will appear on the screen simultaneously and then disappear. An arrow will appear in the location of one of the pictures (\< or \>). Participants are asked to quickly identify the direction of the arrow by pressing a button. In the active training task, the arrow will replace the neutral pictures 80% of the time.

Active attention training condition
Control ConditionBEHAVIORAL

Participants will complete a computerized probe-discrimination task from their home computer or handheld electronic device 3 times per day for one week. Each training session will consist of 160 trials. In each trial, two pictures (smoking-related or neutral) will appear on the screen simultaneously and then disappear. An arrow will appear in the location of one of the pictures (\< or \>). Participants are asked to quickly identify the direction of the arrow by pressing a button. In the control training task, the arrow will replace the neutral and smoking-related pictures with equal frequency.

Control condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65.
  • Familiarity with a computer keyboard and mouse.
  • Must own a iPhone, iPod Touch, or Google Android-based phone (such as the Droid or Nexus One) or have regular access to the Internet via personal computer.
  • Current regular smoker, as defined by self-reported use of at least 1 year and a current average of at least 10 cigarettes smoked per day.

You may not qualify if:

  • \. Individuals with current suicidality (determined by a score of 2 or 3 on item 9 of the Beck Depression Inventory given following consent) will be excluded from further participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Samantha Moshier, MA

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2011

First Posted

October 25, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

US(1)