Clinical trial NCT00639093: A Virtual Arm to Stop Smoking
Official title: A Virtual Arm to Stop Smoking. A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: cigarette smoking
psychoeducational and motivational program
virtual reality
Lead sponsor: Universite du Quebec en Outaouais
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.
timeFrame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Secondary outcomes:
measure: Tiffany's Urge to Smoke Questionnaire
timeFrame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Other outcomes:
Locations:
city: Jonquière
country: Canada
facility: GRAP - Clinique de psychologie au travail
state: Quebec
Study officials:
affiliation: G.R.A.P.
name: Benoit Girard, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: U.Q.O.
name: Stephane Bouchard, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.