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.
Stine, SM., Heil, SH., Kaltenbach, K., Martin, PR., Coyle, MG., Fischer, G., ... Jones, H. (2009). Characteristics of opioid-using pregnant women who accept or refuse participation in a clinical trial: Screening results from the MOTHER study. American Journal of Drug and Alcohol Abuse, 35(6), 429-433. DOI: 10.3109/00952990903374080