Mooney 2007.
Methods | Design: RCT Country: USA Recruitment methods: not reported Setting: outpatient research clinic, located at a university medical centre |
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Participants | Inclusion criteria: women; aged 20–65 years; physically healthy; smoking ≥ 10 cigarettes per day; no current DSM‐IV Axis 1 disorder Exclusion criteria: pregnancy/breastfeeding; current treatment with bupropion or other smoking cessation medication Participants randomised: 55 participants (mean age 42.1 years (SD 10); 100% women; 61.8% white) |
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Interventions | Aim of intervention: to provide feedback on medication use (using electronic MEMS to increase bupropion adherence. Intervention: provision of additional feedback on adherence levels, given by a CBT therapist. Following baseline assessment all participants began 7 weeks of open‐label treatment with bupropion SR 300 mg dispensed in MEMS bottles (containing a computer chip that recorded the times when bottle opening occurred). In addition, all participants received individual weekly CBT sessions for smoking cessation, focusing on identification of high‐risk situation for smoking, coping skills training and lapse recovery strategies. In the intervention condition the weekly CBT was increased in duration by 10 minutes a session, during which time the MEMS feedback was given in graphical form and the treatment regimen was clarified. Problem‐solving techniques were used to help the participant to tailor the regimen to their schedule by associating medication taking with regular activities or routines. Potential barriers to adherence identified and strategies for removing barriers discussed. Participants were encouraged to self‐monitor tablet consumption on daily diaries reviewed at the next therapy session. Control: as above but without the extra 10 minutes added to each session for enhanced therapy. |
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Outcomes | Primary adherence outcome (dichotomous data): rates of full adherence, i.e. 2 doses taken per day in an optimal schedule (ITT data). Assessed daily over 7‐week treatment period, objectively using MEMS bottles. Other adherence outcomes: rates of dose adherence, i.e. 2 doses taken per day over 7‐week treatment period. Secondary outcomes: biochemically validated abstinence at week 6 (selected as abstinence outcome by review authors. as most consistent with adherence outcome time point but there is no useable data in the report); biochemically validated abstinence at week 3. |
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Notes | Authors contacted in 2015 to request data for secondary abstinence outcome but no response received. Funded by National Institute on Drug Abuse. GlaxoSmithKline provided the bupropion SR. No information on conflicts of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details given to enable judgement. |
Allocation concealment (selection bias) | Unclear risk | No details given to enable judgement. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not clear that outcome assessors were blinded, but because MEMS monitoring data used it was unlikely that this constituted a clear risk of bias. Primary adherence outcome was only measured objectively using MEMS monitoring data. Abstinence biochemically validated. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were no differences in attrition between arms (p. 878, paragraph 2), but more than 50% of participants did not complete the study. Data reported for the primary outcome appeared to refer to all randomised participants. |
Selective reporting (reporting bias) | Unclear risk | Unable to find any trial registration or published protocol. |
Consistency in intervention delivery | Unclear risk | No details given to enable judgement. |
Summary risk of bias | High risk | Summary risk of bias assessed as high. |