Trial Outcomes & Findings for A Virtual Arm to Stop Smoking (NCT NCT00639093)

NCT ID: NCT00639093

Last Updated: 2012-07-02

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 91 participants
• Primary outcome timeframe: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
• Results posted on: 2012-07-02

Participant Flow

Medical clinic in the province of Quebec.

Participant milestones

Measure	VR - Cigarettes 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).	VR - Balls (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).
Overall Study STARTED	45	46
Overall Study COMPLETED	45	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Virtual Arm to Stop Smoking

Baseline characteristics by cohort

Measure	VR - Cigarettes n=45 Participants 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).	VR - Balls (Control) n=46 Participants 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).	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Canada	45 participants n=5 Participants	46 participants n=7 Participants	91 participants n=5 Participants
Nicotine addiction	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	VR - Cigarettes n=45 Participants 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).	VR - Balls (Control) n=46 Participants 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).
Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.	45 participants	46 participants

SECONDARY outcome

Timeframe: Weeks 1, 4, 6, 12, 24 and 12-month follow-up

Outcome measures

Outcome data not reported

Adverse Events

VR - Cigarettes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VR - Balls (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benoît Girard

GRAP, Clinique de Psychologie au Travail

Phone: 418-542-2030

Email: g.r.a.p@videotron.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place