Characteristics of opioid-using pregnant women who accept or refuse participation in a clinical trial: Screening results from the MOTHER study

Background:Although concerns arise about the generalizability of results from Randomized Controlled Trials (RCTs), few studies systematically examine this issue. Objectives: This study compared the characteristics of 427 opioid-using pregnant women who did (n = 208) and did not consent (n = 219) to enrollment in a multicenter clinical trial of agonist medications (i.e., the MOTHER study). Methods: Logistic regression models were used to compare consenters and non-consenters to examine the effect of screening variables on the likelihood of consenting. Results: Of nine characteristics examined, most differences did not reach statistical significance. Consenting participants were less likely than non-consenting women to be currently enrolled in a methadone maintenance program (74.5% vs. 84.5%, p = .01). Conclusion and Scientific Significance: These data show that the recruited sample of drug-dependent pregnantwomen enrolled in an intensiveRCTis representative of the larger population of treated opioid-dependent patients and supports the generalizability of randomized controlled trials in this population.