Table 1.

Datasets and studies used in this investigation

Study	Subjects	Study design	Measure	Role in this study
Datasets analyzed
ALO-01-07-106	27 opioid-experienced, non-dependent men	Crossover study: MS 30 mg IV; MS 30 mg + NTX 1.2 mg IV; placebo IV	VAS Drug High score 0–100 mm	Drug high dataset analyzed to determine CID Dataset used in distribution-based method
ALO-01-07-205	32 opioid-experienced, non-dependent adults	Crossover study: IRMS 120 mg PO; crushed ALO-01 PO; intact ALO-01 PO; placebo PO	VAS Drug High score 0–100 mm	Drug high dataset analyzed to determine CID Dataset used in distribution- based method
Comer et al. [10]	12 heroin-dependent men	Single dose of sustained-release depot NTX 192 mg or 384 mg followed by heroin 0, 6.25, 12.5, 18.75, and 25 mg IV once per week for 6 weeks	VAS Drug High score 0–100 mm with 25 mg heroin	Determination of CIDDose and CIDWeek1–4 Dataset used in anchor-based approach
Studies used to provide anchors for determining CID
Comer et al. [11]	60 heroin-dependent adults	Sustained-release depot NTX 192 mg or 384 mg at Week 1 and Week 5	Retention rates	Evaluation of retention rate as anchor for Comer et al. [10] drug high CIDDose
Sullivan et al. [12]	5 heroin-dependent adults	Sustained-release depot NTX 384 mg at Week 1 plus doses of 0, 6.25, 12.5, 18.75, and 25 mg heroin IV for 6 weeks; each week, subjects received 1 of 4 heroin doses or placebo on any given day	Heroin self- administration (mean heroin break point)	Evaluation of heroin self- administration rates at Week 4 versus Week 1 as anchor for Comer et al. [10] drug high CIDWeek1–4

CID clinically important difference, NTX naltrexone, VAS visual analog scale, MS morphine sulphate, IV intravenous, PO by mouth, IRMS immediate-release morphine sulphate