SmokingNCT00862927
Cue Reactivity in Virtual Reality: The Role of Context
An observational study of Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Breath Sample, Saliva Sample and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Smokers, 18 years of age or older.
Who may be able to join
- 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
Who cannot join
- 1) Self-report history of motion sickness or vertigo
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Smoking
- Being tested
- Breath Sample, Saliva Sample, Questionnaire, View Virtual Reality Scenes
- Keywords
- 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
- Medical subject headings
- Smoking, Smoking Cessation, Cigarette Smoking, Tobacco Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath SampleOther
Breathe into machine measuring carbon monoxide.
Saliva SampleOther
Chew cotton ball for 30 seconds for cotinine measurement.
QuestionnaireBehavioural
6 surveys, taking approximately 30 minutes total.
View Virtual Reality ScenesBehavioural
Also called VR
Use virtual reality helmet and hand-held controller to answer questions about 4 viewing scenes while wearing physiological measurement skin sensors, approximately 6 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cue reactivity in virtual reality | Breath Scan + Saliva Sample + Questionnaires + View Virtual Reality Scenes Receives: Other: Breath Sample; Other: Saliva Sample; Behavioral: Questionnaire; Behavioral: View Virtual Reality Scenes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Total participation time about 90 minutes; Overall study period (assessment & surveys) approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian L. Carter, PhD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862927
- Sponsor's protocol ID
- 2008-0544
- Status last verified
- Jun 2012
- First submitted
- 16 Mar 2009
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue Reactivity in Virtual Reality: The Role of Context
- ClinicalTrials.gov ID
- NCT00862927
- Acronym / sponsor ID
- 2008-0544
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Cigarette Smoking, Tobacco Smoking, Cue Reactivity, Virtual Reality, VR, Contextual Cues, Explicit Smoking Cues
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cue reactivity in virtual reality | – | Other: Breath Sample, Other: Saliva Sample, Behavioral: Questionnaire, Behavioral: View Virtual Reality ScenesBreath Scan + Saliva Sample + Questionnaires + View Virtual Reality Scenes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Smokers, 18 years of age or older.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 1) Self-report history of motion sickness or vertigo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath SampleBreathe into machine measuring carbon monoxide. | Other | Cue reactivity in virtual reality |
| Saliva SampleChew cotton ball for 30 seconds for cotinine measurement. | Other | Cue reactivity in virtual reality |
| Questionnaire6 surveys, taking approximately 30 minutes total. | Behavioural | Cue reactivity in virtual reality |
| View Virtual Reality ScenesAlso: VRUse virtual reality helmet and hand-held controller to answer questions about 4 viewing scenes while wearing physiological measurement skin sensors, approximately 6 minutes. | Behavioural | Cue reactivity in virtual reality |
Primary outcome
Differences in craving and arousal among four scenarios based on repeated survey measure
Time frame: Total participation time about 90 minutes; Overall study period (assessment & surveys) approximately 2 years
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.
Results and safety
The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian L. Carter, PhD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in craving and arousal among four scenarios based on repeated survey measure (time frame: Total participation time about 90 minutes; Overall study period (assessment & surveys) approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.