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

Susan M. Stine, Sarah H. Heil, Karol Kaltenbach, Peter R. Martin, Mara G. Coyle, Gabriele Fischer, Amelia M. Arria, Peter Selby, Hendree E. Jones

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)429-433
Number of pages5
JournalAmerican Journal of Drug and Alcohol Abuse
Volume35
Issue number6
DOIs
StatePublished - Dec 15 2009

Keywords

  • Buprenorphine
  • Methadone
  • Opiates
  • Opioids
  • Pregnant women
  • Substance abuse
  • Substance use
  • Treatment acceptance

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Clinical Psychology
  • Psychiatry and Mental health

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