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A Virtual Arm to Stop Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00639093
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : July 31, 2009
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
Stephane Bouchard, Universite du Quebec en Outaouais

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 19, 2008
Results First Submitted Date  ICMJE July 30, 2009
Results First Posted Date  ICMJE July 31, 2009
Last Update Posted Date July 2, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Tiffany's Urge to Smoke Questionnaire [ Time Frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Virtual Arm to Stop Smoking
Official Title  ICMJE A Virtual Arm to Stop Smoking. A Comparative Study
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cigarette Smoking
Intervention  ICMJE
  • Behavioral: psychoeducational / motivational combined with crushing

    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).

  • Behavioral: psychoeducational / motivational combined with control

    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 Arms  ICMJE
  • Experimental: 1

    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).

    Intervention: Behavioral: psychoeducational / motivational combined with crushing
  • Active Comparator: 2

    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).

    Intervention: Behavioral: psychoeducational / motivational combined with control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2009)
91
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2008)
90
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult smoker
  • aged 18 - 65
  • willing to stop smoking
  • at least 10 cigarettes per day in the last year

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00639093
Other Study ID Numbers  ICMJE GRAP-CRC-cyberpsychologie
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephane Bouchard, Universite du Quebec en Outaouais
Study Sponsor  ICMJE Universite du Quebec en Outaouais
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benoit Girard, M.D. G.R.A.P.
Study Chair: Stephane Bouchard, Ph.D. U.Q.O.
PRS Account Universite du Quebec en Outaouais
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP