Cigarette SmokingNCT00639093
A Virtual Arm to Stop Smoking
A study testing psychoeducational / motivational combined with crushing in people with Cigarette Smoking, run by Universite du Quebec en Outaouais at 1 site in Canada.
Trial summary
The investigators reported in a pilot study presented at last year's Cybertherapy Conference (Girard \& Turcotte, 2007) that using an action-cue exposure strategy in virtual reality (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- psychoeducational / motivational combined with crushing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult smoker
- aged 18 - 65
- willing to stop smoking
- at least 10 cigarettes per day in the last year
Who cannot join
- receiving concomitant treatment for smoking (e.g., patches or varenicline)
- weight problems : Body Mass Index < 15 kg or > 45.5 kg
- suffering from a mental disorder, such as major depression, schizophrenia, etc.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GRAP - Clinique de psychologie au travail
Jonquière, Quebec, G7X 0A4
About this study
Official title: A Virtual Arm to Stop Smoking. A Comparative Study
The investigators reported in a pilot study presented at last year's Cybertherapy Conference (Girard \& Turcotte, 2007) that using an action-cue exposure strategy in virtual reality (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.
The investigators are pursuing research in this area with a randomized control trial based on 90 smokers who will receive a brief psychosocial smoking cessation program (25 people are enrolled so far and we expect to finish the study before the conference). During the first four weeks of an eight-session psychoeducational and motivational program, all participants will be immersed in VR. During the immersions in VR, 45 of the participants will use a virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the virtual arm to catch virtual fruits (control condition).
Read more
The smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence reported in the diaries). The success the program will be compared based on the number of subjects who quitted or reduced their smoking frequency. The severity of addiction will be assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1 through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive Tendencies Questionnaire will be administered and after each VR session participants will fill two questionnaires addressing presence and cybersickness. The comparative impact of both treatments will be tested with repeated measures ANOVAs (and planned contrasts) with sufficient power to detect medium effect sizes.
The main goal of our study is show that crushing virtual cigarettes can boost the impact of a behavioural program dedicated to cigarette addiction.
Read the detailed description
A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.
- Conditions
- Cigarette Smoking
- Being tested
- psychoeducational / motivational combined with crushing, psychoeducational / motivational combined with control
- Keywords
- cigarette smoking, psychoeducational and motivational program, virtual reality
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducational / motivational combined with crushingBehavioural
All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).
psychoeducational / motivational combined with controlBehavioural
All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer). Receives: Behavioral: psychoeducational / motivational combined with crushing |
| 2 | Active comparator | All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer). Receives: Behavioral: psychoeducational / motivational combined with control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.
Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.
Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up).
Measured: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Secondary outcomes (1)
Tiffany's Urge to Smoke Questionnaire
Measured: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite du Quebec en Outaouais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Bouchard, Universite du Quebec en Outaouais
- Investigators
- Benoit Girard, M.D., Principal investigator, G.R.A.P.Stephane Bouchard, Ph.D., Study chair, U.Q.O.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639093
- Sponsor's protocol ID
- GRAP-CRC-cyberpsychologie
- Status last verified
- Jun 2012
- First submitted
- 12 Mar 2008
- Last updated
- 2 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Girard, B., & Turcotte, V. (2007). A virtual arm to stop smoking, a perceptual learning experiment. In N. Appel & H. Hoffman (Chairs), Addictions. Symposium presented at the Cybertherapy 12 Conference, in June in Washington, D.C.
Martin RA, Rohsenow DJ, MacKinnon SV, Abrams DB, Monti PM. Correlates of motivation to quit smoking among alcohol dependent patients in residential treatment. Drug Alcohol Depend. 2006 Jun 9;83(1):73-8. doi: 10.1016/j.drugalcdep.2005.10.013. Epub 2005 Nov 28.
PubMed 16314049Girard B, Turcotte V, Bouchard S, Girard B. Crushing virtual cigarettes reduces tobacco addiction and treatment discontinuation. Cyberpsychol Behav. 2009 Oct;12(5):477-83. doi: 10.1089/cpb.2009.0118.
PubMed 19817561
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Arm to Stop Smoking. A Comparative Study
- ClinicalTrials.gov ID
- NCT00639093
- Acronym / sponsor ID
- GRAP-CRC-cyberpsychologie
- Conditions
- Cigarette Smoking
- Keywords
- cigarette smoking, psychoeducational and motivational program, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Universite du Quebec en OutaouaisUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 31 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators reported in a pilot study presented at last year's Cybertherapy Conference (Girard \& Turcotte, 2007) that using an action-cue exposure strategy in virtual reality (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.
The investigators are pursuing research in this area with a randomized control trial based on 90 smokers who will receive a brief psychosocial smoking cessation program (25 people are enrolled so far and we expect to finish the study before the conference). During the first four weeks of an eight-session psychoeducational and motivational program, all participants will be immersed in VR. During the immersions in VR, 45 of the participants will use a virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the virtual arm to catch virtual fruits (control condition).
The smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence reported in the diaries). The success the program will be compared based on the number of subjects who quitted or reduced their smoking frequency. The severity of addiction will be assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1 through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive Tendencies Questionnaire will be administered and after each VR session participants will fill two questionnaires addressing presence and cybersickness. The comparative impact of both treatments will be tested with repeated measures ANOVAs (and planned contrasts) with sufficient power to detect medium effect sizes.
The main goal of our study is show that crushing virtual cigarettes can boost the impact of a behavioural program dedicated to cigarette addiction.
Detailed description
A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: psychoeducational / motivational combined with crushingAll participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer). |
| 2 | Active comparator | Behavioral: psychoeducational / motivational combined with controlAll participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult smoker
- aged 18 - 65
- willing to stop smoking
- at least 10 cigarettes per day in the last year
Key exclusion criteria (3 listed)
- receiving concomitant treatment for smoking (e.g., patches or varenicline)
- weight problems : Body Mass Index < 15 kg or > 45.5 kg
- suffering from a mental disorder, such as major depression, schizophrenia, etc.
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 |
|---|---|---|
| psychoeducational / motivational combined with crushingAll participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer). | Behavioural | 1 |
| psychoeducational / motivational combined with controlAll participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer). | Behavioural | 2 |
Primary outcome
Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.
Time frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample. Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up).
1 secondary outcome
Tiffany's Urge to Smoke Questionnaire
Time frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundGirard, B., & Turcotte, V. (2007). A virtual arm to stop smoking, a perceptual learning experiment. In N. Appel & H. Hoffman (Chairs), Addictions. Symposium presented at the Cybertherapy 12 Conference, in June in Washington, D.C.
- Background: PubMed 16314049Martin RA, Rohsenow DJ, MacKinnon SV, Abrams DB, Monti PM. Correlates of motivation to quit smoking among alcohol dependent patients in residential treatment. Drug Alcohol Depend. 2006 Jun 9;83(1):73-8. doi: 10.1016/j.drugalcdep.2005.10.013. Epub 2005 Nov 28.
- Derived from this study: PubMed 19817561Girard B, Turcotte V, Bouchard S, Girard B. Crushing virtual cigarettes reduces tobacco addiction and treatment discontinuation. Cyberpsychol Behav. 2009 Oct;12(5):477-83. doi: 10.1089/cpb.2009.0118.
- Click here for more information about this study about the virtual armLink provided by the sponsor.
- For more information about using VR to treat smokingLink 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.
Benoit Girard, M.D. principal investigator
G.R.A.P.
Stephane Bouchard, Ph.D. study chair
U.Q.O.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducational / motivational combined with crushing in people with Cigarette Smoking, run by Universite du Quebec en Outaouais at 1 site in Canada.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jul 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 Canada. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. (time frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639093, which also lists 3 linked publications.
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 2 Jul 2012.