NCT00862927

Brief Summary

The objectives of this proposal are to examine the role of context in a virtual reality (VR) environment and to explore the extent to which cues (i.e., contextual cues or explicit smoking cues) influence craving and physiological arousal within VR. The current study seeks to determine whether smokers, placed in the context of a VR convenience store devoid of explicit smoking cues, will experience less craving and physiological arousal, compared to exposure to the same VR environment containing explicit smoking cues. This important line of inquiry will help clarify the influence of environmental contexts that may contribute to the overall reactivity effects (e.g., craving, arousal) smokers experience when confronted with cues associated with smoking.

Trial Health

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Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

March 16, 2009

Last Update Submit

June 19, 2012

Conditions

Keywords

Smoking CessationCigarette SmokingTobacco SmokingCue ReactivityVirtual RealityVRContextual CuesExplicit Smoking CuesCravingPhysiological ArousalNicotine DependenceBreath SampleSaliva TestQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Differences in craving and arousal among four scenarios based on repeated survey measure

    Analyses on craving and arousal measures between-subjects to discern any differences in craving and arousal among the two sets of scenarios. After providing breath and saliva samples, seated participants complete questionnaires and smoke one cigarette to control for variability in time since last cigarette. First 5 questionnaires take approximately 35 minutes to complete, and another, completed after the VR session, approximately 10 minutes.

    Total participation time about 90 minutes; Overall study period (assessment & surveys) approximately 2 years

Study Arms (1)

Cue reactivity in virtual reality

Breath Scan + Saliva Sample + Questionnaires + View Virtual Reality Scenes

Other: Breath SampleOther: Saliva SampleBehavioral: QuestionnaireBehavioral: View Virtual Reality Scenes

Interventions

Breathe into machine measuring carbon monoxide.

Cue reactivity in virtual reality

Chew cotton ball for 30 seconds for cotinine measurement.

Cue reactivity in virtual reality
QuestionnaireBEHAVIORAL

6 surveys, taking approximately 30 minutes total.

Cue reactivity in virtual reality

Use virtual reality helmet and hand-held controller to answer questions about 4 viewing scenes while wearing physiological measurement skin sensors, approximately 6 minutes.

Also known as: VR
Cue reactivity in virtual reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Smokers, 18 years of age or older.

You may qualify if:

  • At least 18 years old
  • Self-report of smoking at least 10 cigarettes per day
  • Expired carbon monoxide (CO) equal to or greater than 10 ppm
  • English speaking and able to read at \> 6th grade level
  • Not interested in quitting smoking in next 30 days

You may not qualify if:

  • \) Self-report history of motion sickness or vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

SmokingSmoking CessationCigarette SmokingTobacco SmokingTobacco Use Disorder

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Brian L. Carter, PhD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations