| Methods |
Setting: clinic, USA
Recruitment: community volunteers motivated to enrol in trial of cessation medication |
| Participants |
463 smokers (226 in relevant arms); 50% female, av. age 36‐41 across arms, av.cpd 22
Providers: trained college‐aged or bachelor's level staff, supervised by experienced counsellor |
| Interventions |
Factorial trial of bupropion or placebo pharmacotherapy and counselling versus support
1. Bupropion & counselling; 8 x 10 min sessions, 2 prequit, TQD, 5 over 4 wks, additional office visits without counselling
2. Bupropion & psychoeducation (not used in this review)
3. Placebo & counselling (not used in this review)
4. Placebo & psychoeducation about medication, support & encouragement. Same no. of office visits, 80 mins less contact time than 1. |
| Outcomes |
7 day PP abstinence at 12m
Validation: CO ≤10 ppm |
| Notes |
1 vs 4 used as a test of combined intervention. Others arms do not contribute to this review. Classified as 91‐300 mins because of additional contact time during office visits.
Also contributes to Cochrane reviews of antidepressants (Hughes 2014) (collapsing behavioural conditions) and individual behavioural counselling (Lancaster 2005) (collapsing pharmacotherapy) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
'Random number table' |
| Allocation concealment (selection bias) |
Low risk |
'Staff who screened and enrolled participants were unaware of the experimental condition to be assigned' |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
In relevant arms 24 (11%) failed to attend quit date visit and 62 (27%) lost to follow‐up at 12m, no difference by condition, all included as smokers in ITT analysis |
