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Cue Reactivity in Virtual Reality: The Role of Context


N/A
18 Years
N/A
Not Enrolling
Both
Smoking

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Trial Information

Cue Reactivity in Virtual Reality: The Role of Context


If you agree to take part in this study, you will complete a breath scan test, a saliva
sample, complete questionnaires, smoke 1 cigarette, have your physiological measurements
recorded, and view virtual reality scenes.

Breath Sample:

After signing the consent form, you will be asked to provide a breath scan to show how
recently you smoked. To provide a breath sample, you will hold your breath for 15 seconds
and exhale (breathe out) through a small cardboard tube into a small machine. This machine
measures the amount of carbon monoxide in your breath, which provides an estimate of how
many cigarettes you have recently smoked. If this measurement shows you are a very light
smoker, you may not be able to take part in the rest of this study.

Saliva Sample:

You will be asked to provide a saliva sample in order to measure cotinine, which is a
substance related to nicotine that is found in the body after smoking recently. You will be
asked to place a small cotton roll in your mouth and gently chew the roll for 30 seconds.
You will then remove the roll and place it in a small container. The container will not be
labeled with your name, but only a study ID number. Only the study staff will have access
to this number. Once the samples have been measured for levels of cotinine, the samples will
be destroyed.

Questionnaires:

You will fill out a questionnaire that includes questions about your age, smoking history,
marital status, ethnicity, and other basic information. This questionnaire should take
about 3 minutes to complete. You will also complete 5 additional questionnaires that will
ask about your mood, thoughts and feelings, and smoking behavior. These questionnaires
should take about 30 minutes total to complete.

While completing the questionnaires, you will be asked to smoke 1 cigarette (any brand).
You will be told to bring in your own cigarettes for this part of the study. However, if
you forget to bring them in, the study staff will be able to provide one to you. This will
be done so that all participants will have smoked their last cigarette at about the same
time before viewing the virtual reality scenes.

Physiological Measurements:

Your heart rate and the amount you sweat will be recorded after completing the
questionnaires and during each virtual reality scene (described below) by applying small
sensors to your skin.

After you have completed the questionnaires, you will sit in a recliner and the sensors will
be placed on your rib cage and hand. The sensors that measure heart rate will be placed in
the following locations: your lower left rib cage, just under your right collar bone, and
just under your left collar bone. The sensors that measure the amount you sweat will be
placed on the palm of your hand.

The Virtual Reality Scenes:

You will sit in a recliner and be asked to put on a virtual reality helmet, which has
goggles and noise-cancelling headphones. You will be told how to wear the helmet and use the
hand-held controller to answer the questions you will see after you have finished viewing
each virtual reality scene.

You will view 2 virtual reality scenes that will either show images of nature, such as fish,
or images of a convenience store, such as a parking lot of a gasoline station and the inside
of store. The experience of virtual reality may involve other senses as well. For example,
you may hear, smell, and feel sensations (such as mild vibrations) that are associated with
the scenes you are viewing.

After each virtual reality scene that you view, you will answer a single question about your
desire to smoke. It should take less than 1 minute to complete the question. You will view
two virtual reality scenes, with a five minute rest period in between. It will take about 6
minutes to view each pair of scenes. After the scenes have ended, the equipment and sensors
will be removed, and you will be asked to complete a questionnaire that will ask about your
experiences and feelings about virtual reality. This questionnaire should take less than 10
minutes to complete.

Length of Study:

Once you have finished viewing the virtual reality scenes and completed the last
questionnaire, your participation in this study will be over. Your total participation time
in this study should take about 90 minutes.

This is an investigational study. Up to 75 people will take part in this study. All will be
enrolled at M. D. Anderson.


Inclusion Criteria:



1. At least 18 years old

2. Self-report of smoking at least 10 cigarettes per day

3. Expired carbon monoxide (CO) equal to or greater than 10 ppm

4. English speaking and able to read at > 6th grade level

5. Not interested in quitting smoking in next 30 days

Exclusion Criteria:

1) Self-report history of motion sickness or vertigo

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Brian L. Carter, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0544

NCT ID:

NCT00862927

Start Date:

March 2009

Completion Date:

July 2011

Related Keywords:

  • Smoking
  • Smoking Cessation
  • Cigarette Smoking
  • Tobacco Smoking
  • Cue Reactivity
  • Virtual Reality
  • VR
  • Contextual Cues
  • Explicit Smoking Cues
  • Craving
  • Physiological Arousal
  • Nicotine Dependence
  • Breath Sample
  • Saliva Test
  • Questionnaire
  • Smoking

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030