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 pregnant women enrolled in an intensive RCT is representative of the larger population of treated opioid-dependent patients and supports the generalizability of randomized controlled trials in this population.