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N/A N=91 Randomized Treatment

A Virtual Arm to Stop Smoking

Cigarette Smoking

Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. — 45; 46 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
psychoeducational / motivational combined with crushing (Behavioral); psychoeducational / motivational combined with control (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Universite du Quebec en Outaouais
Primary completion
Jun 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.
45; 46
SECONDARY
Tiffany's Urge to Smoke Questionnaire

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.

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 45.5 kg
  • suffering from a mental disorder, such as major depression, schizophrenia, etc.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00639093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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