Jones 2005.

Study characteristics
Methods	Randomised controlled trial Double‐blind
Participants	Participants: 30 pregnant adults; mean age 30.1 years; 75% African‐American, 20% white, 5% other; 55% unemployed but seeking work, 40% unemployed and not seeking work, 5% homemakers; mean years of education 10.2; use of cocaine in past 30 days: 75%; opioid use: > 4 x day: 55% Mean gestational age at entry: 23 weeks Inclusion criteria: estimated gestational age of 16 to 30 weeks; opioid‐dependent pregnant females meeting DSM‐IV criteria Exclusion criteria: current diagnosis of alcohol abuse or dependence; self‐reported use of benzodiazepines; serious medical illness; diagnosis of preterm labour; evidence of fetal malformation; positive HIV test
Interventions	(1) Oral methadone (15 participants) versus (2) oral buprenorphine (15 participants). Dose of methadone: mean 60 mg/day; dose of buprenorphine: mean 12 mg /day Setting: inpatients Follow‐up mean: 18 weeks
Outcomes	Neonatal outcomes: number of neonates treated for NAS; peaks of NAS score; length of neonatal hospitalisation; birth weight; child health status; APGAR score Maternal outcomes: retention; illicit drug use (urinalysis)
Notes	Country: USA Funding: grants DA R01 12220 from the National Institute on Drug Abuse and M01RR‐02719 from the General Clinical Research Centers Program of the National Center of Research Resources, National Institutes of Health Conflict of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "They were assigned to one of the two treatment groups using a computerized dynamic balanced randomisation".
Allocation concealment (selection bias)	Low risk	Quote: "Research staff, with no other study involvement, generated the randomised allocation sequence".
Blinding of participants and personnel (performance bias) subjective outcomes	Low risk	Once medically cleared and randomised, participants were switched from their individualised dose of immediate‐release morphine onto an equivalent dose of double‐blind study medication. To maintain the double‐blind, the actual dose changes were known only to pharmacy staff.
Blinding of participants and personnel (performance bias) objective outcomes	Low risk	Once medically cleared and randomised, participants were switched from their individualised dose of immediate‐release morphine onto an equivalent dose of double‐blind study medication. To maintain the double‐blind, the actual dose changes were known only to pharmacy staff.
Blinding of outcome assessment (detection bias) subjective outcomes	Low risk	Once medically cleared and randomised, participants were switched from their individualised dose of immediate‐release morphine onto an equivalent dose of double‐blind study medication. To maintain the double‐blind, the actual dose changes were known only to pharmacy staff.
Blinding of outcome assessment (detection bias) objective outcomes	Low risk	Once medically cleared and randomised, participants were switched from their individualised dose of immediate‐release morphine onto an equivalent dose of double‐blind study medication. To maintain the double‐blind, the actual dose changes were known only to pharmacy staff.
Incomplete outcome data (attrition bias) All outcomes	High risk	Of the 30 randomised patients, 20 delivered while enrolled in the study; the remaining 10 dropped out during the study. Of those randomised to buprenorphine, reasons for dropouts included: discharged for medical condition (n = 1), missed consecutive dosing days (n = 4) and elected to withdraw (n = 1). Of those randomised to methadone, reasons for discharge included: missed consecutive dosing days (n = 3) and elected to withdraw (n = 1). COMMENT: high dropouts (40%) in the methadone group and unbalanced (26% in the buprenorphine group)
Selective reporting (reporting bias)	Unclear risk	No protocol available