Background
Methods
Study design
Eligibility and screening
Study procedures
Pharmacological interventions
NRT group
NRT+ group
VR group
Measures
Statistical analyses
Results
Enrollment and follow-up
Demographic, medical and smoking profile
n (%) | Overall | NRT | NRT+ | VR |
---|---|---|---|---|
Age (M, SD) | 48.61 (10.8) | 48.13 (11.1) | 48.57 (10.5) | 49.11 (10.8) |
Sex | ||||
Male | 395 (53.6) | 137 (55.9) | 131 (53.5) | 127 (51.4) |
Female | 342 (46.6) | 108 (44.1) | 114 (46.5) | 120 (48.6) |
Marital status | ||||
Married/common law | 340 (46.3) | 120 (49.0) | 107 (43.9) | 113 (46.3) |
Divorced/separated/widowed | 232 (31.7) | 69 (28.1) | 79 (32.3) | 84 (34.4) |
Single/never married | 161 (22.0) | 56 (22.9) | 58 (23.8) | 47 (29.2) |
Years of education (M, SD) | 14.13 (3.0) | 13.97 (2.7) | 14.19 (3.0) | 14.21 (3.2) |
Employment status | ||||
Full/part time | 449 (61.3) | 157 (64.4) | 145 (59.5) | 147 (60.1) |
Homemaker/retired/unemployed | 158 (21.6) | 49 (20.0) | 51 (20.8) | 58 (23.6) |
Disability leave | 126 (17.1) | 38 (15.6) | 48 (19.7) | 40 (16.3) |
Annual household income (Canadian dollars) | ||||
19,999 or less | 162 (22.7) | 50 (20.7) | 61 (25.8) | 51 (21.6) |
20,000–39,999 | 147 (20.6) | 51 (34.7) | 47 (19.9) | 49 (20.8) |
40,000–69,999 | 216 (30.3) | 76 (31.5) | 67 (28.4) | 73 (30.9) |
70,000 or more | 188 (26.4) | 64 (26.6) | 61 (26.8) | 63 (26.7) |
Lifetime psychiatric diagnosis (%) | 435 (59.0) | 144 (58.5) | 143 (58.4) | 148 (58.9) |
Smoking characteristics (M, SD) | ||||
Cigarettes smoked per day | 23.2 (10.8) | 22.4 (11.3) | 24.0 (10.9) | 23.3 (10.1) |
Cumulative years smoked | 31.0 (11.7) | 30.5 (12.2) | 30.9 (11.3) | 31.7 (11.5) |
Fagerstrom test of nicotine dependence | 6.1 (2.2) | 6.0 (2.2) | 6.3 (2.2) | 6.1 (2.3) |
Number of previous quit attempts | 4.6 (5.4) | 4.3 (4.5) | 4.2 (4.5) | 5.2 (6.7) |
Motivation to quita | 8.7 (1.5) | 8.7 (1.4) | 8.7 (1.6) | 8.7 (1.4) |
Confidence to quita | 7.4 (2.2) | 7.3 (2.2) | 7.4 (2.1) | 7.4 (2.2) |
Number of other smokers in the household | 1.0 (1.0) | 1.1 (0.9) | 1.0 (0.9) | 1.1 (1.2) |
Intervention
Smoking abstinence
NRT | NRT+ | VR | |
---|---|---|---|
Primary outcome: continuous abstinence at week 5–52 | |||
Abstinence, n (%) | 23 (10) | 29 (12.4) | 36 (15.3) |
OR (97.5 % CI) | REF | 1.28 (0.67–2.43) | 1.62 (0.87–3.01) |
Unadjusted | |||
Adjusted | REF | 1.34 (0.67–2.70) | 1.84 (0.94–3.58) |
Secondary outcome: 7-day point prevalence abstinence at week 52 | |||
n (%) | 34 (14.8) | 43 (18.5) | 51 (21.7) |
Unadjusted | REF | 1.31 (0.76–2.25) | 1.60 (0.94–2.70) |
Adjusted | REF | 1.31 (0.79–2.37) | 1.84 (1.04–3.26)* |
Secondary outcome: continuous abstinence at week 5–22 | |||
n (%) | 38 (15.8) | 59 (24.5) | 65 (27.1) |
Unadjusted | REF | 1.51 (0.88–2.57) | 2.01 (1.20–3.36)** |
Adjusted | REF | 1.67 (0.95–2.94) | 2.18 (1.25–3.80)** |
Secondary outcome: 7-day point prevalence at week 22 | |||
n (%) | 38 (15.8) | 59 (24.5) | 65 (27.1) |
Unadjusted | REF | 1.72 (1.04–2.85)* | 1.96 (1.20–3.23)** |
Adjusted | REF | 1.87 (1.09–3.20)* | 2.09 (1.22–3.57)** |
Secondary outcome: continuous abstinence week 5–10 | |||
n (%) | 72 (29.4) | 94 (38.7) | 98 (39.8) |
Unadjusted | REF | 1.52 (1.00–2.30) | 1.58 (1.04–2.39)* |
Adjusted | REF | 1.62 (1.03–2.56)* | 1.66 (1.04–2.63)* |
Secondary outcome: 7-day point prevalence at week 10 | |||
n (%) | 65 (26.5) | 88 (36.2) | 97 (39.4) |
Unadjusted | REF | 1.57 (1.03–2.41)* | 1.79 (1.17–2.73)** |
Adjusted | REF | 1.65 (1.04–2.61)* | 1.89 (1.19–3.01)** |
Adverse events
Adverse event | Treatment group n (%) | |||
---|---|---|---|---|
NRT | NRT+ | VR |
P
| |
Cardiovascular (e.g., palpitations, tachycardia, chest pain) | 5 (2.0) | 3 (1.2) | 3 (1.2) | 0.687 |
Digestive (e.g., indigestion, nausea, diarrhea, constipation, flatulence) | 48 (19.6) | 64 (26.1) | 139 (56.3) | <0.001a |
Muscular (e.g., hypertonia, join, neck or jaw pain) | 7 (2.9) | 5 (2.0) | 4 (1.6) | 0.632 |
Nervous system (e.g., dizziness, light headedness, tingling fingers) | 24 (9.8) | 27 (11.0) | 31 (12.6) | 0.622 |
Psychiatric (e.g., anxious, disturbed concentration, suicidal ideation) | 12 (4.9) | 9 (3.7) | 18 (7.3) | 0.267 |
Sleep (e.g., abnormal dreams, insomnia, sleep disturbance) | 92 (37.6) | 115 (46.9) | 149 (60.3) | <0.001a |
Fatigue (e.g., drowsy, lethargic) | 9 (3.7) | 19 (7.8) | 43 (17.4) | <0.001a |
Metabolic (e.g., increased appetite, taste perversion) | 13 (5.3) | 14 (5.7) | 23 (9.3) | 0.151 |
Respiratory (e.g., coughing, congestion, shortness of breath) | 6 (2.4) | 9 (3.7) | 10 (4.0) | 0.592 |
Skin (e.g., rash, itchiness, dry skin, redness) | 94 (38.4) | 81 (33.1) | 12 (4.9) | <0.001a |
Other (e.g., eyes difficult to focus, hot flashes, low sex drive) | 21 (8.6) | 19 (7.8) | 48 (19.4) | <0.001a |