A Virtual Arm to Stop Smoking

Cigarette Smoking Clinical Trial

Official title:

A Virtual Arm to Stop Smoking. A Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639093
• Other study ID #: GRAP-CRC-cyberpsychologie
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: June 25, 2012
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2012
• Source: Universite du Quebec en Outaouais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical 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.

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.

Description:

A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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).
• 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).

Locations

Country	Name	City	State
Canada	GRAP - Clinique de psychologie au travail	Jonquière	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Universite du Quebec en Outaouais

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Epub 2005 Nov 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Weeks 1, 4, 6, 12, 24 and 12-month follow-up	No
Secondary	Tiffany's Urge to Smoke Questionnaire		Weeks 1, 4, 6, 12, 24 and 12-month follow-up	Yes

External Links

•   Click here for more information about clinical applications of virtual reality
•   Click here for more information about this study about the virtual arm
•   For more information about using VR to treat smoking