A Virtual Arm to Stop Smoking

• 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: Universite du Quebec en Outaouais
• Information provided by (Responsible Party): Stephane Bouchard, Universite du Quebec en Outaouais

Tracking Information

• First Submitted Date: March 12, 2008
• First Posted Date: March 19, 2008
• Results First Submitted Date: July 30, 2009
• Results First Posted Date: July 31, 2009
• Last Update Posted Date: July 2, 2012
• Study Start Date: March 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Virtual Arm to Stop Smoking
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cigarette Smoking

Intervention

• 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

• 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 *

• 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.
• Girard 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 30, 2009): 91
• Original Estimated Enrollment (submitted: March 12, 2008): 90
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00639093
• Other Study ID Numbers: GRAP-CRC-cyberpsychologie
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stephane Bouchard, Universite du Quebec en Outaouais
• Original Responsible Party: Stephane Bouchard / Professor, Canada Research Chair in Clinical Cyberpsychology, Universite du Quebec en Outaouais
• Current Study Sponsor: Universite du Quebec en Outaouais
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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