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A Clinical Trial of a Program for Pain Management and Opioid Reduction During Pregnancy

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Abstract

A substantial proportion of pregnant women use prescription opioids. However, the lack of efficacy of chronic prescription opioid use for pain, combined with an increased risk of these medications in general and during pregnancy, suggests that the risks of these medications may outweigh the benefits of continued use. Though research has not evaluated non-pharmacological approaches to treat chronic pain during pregnancy, research conducted with the general population outside of pregnancy suggests that cognitive behavioral therapy (CBT) is an effective, non-pharmacological treatment. Therefore, the purpose of this study was to evaluate the effectiveness of CBT for chronic pain paired with shared decision-making for prescription opioid dose reduction among pregnant women with prescription opioid misuse. The study was an open-label, 8-week clinical trial of CBT for chronic pain and shared decision-making for prescription opioid dose reduction. Participants included a clinical sample of 20 pregnant women between the ages of 18 and 45 years who were misusing opioids but did not meet DSM-IV criteria for an opioid use disorder or other substance use disorder. Compared to baseline, at 8 weeks, participants had significant reductions in average prescription opioid morphine equivalent dose, prescription opioid misuse, worst pain ratings, and pain interference in general activity and at work. They did not report improvement in other pain ratings or areas of functioning. This study provides valuable information regarding the preliminary efficacy of CBT for chronic pain paired with shared decision-making among pregnant women misusing prescription opioids. ClinicalTrials.gov: NCT02804152

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Data were analyzed using SPSS.

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Funding

This study was supported by grants from the National Institute on Drug Abuse (NIDA) (K23DA039319 and R34 DA046730, PI: Guille). The sponsors of this study did not play any role in the study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the article for publication.

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Authors

Contributions

CG was involved with the study concept and design, drafting the manuscript, and obtaining funding. MS was involved with statistical analysis and drafting the manuscript. AS was involved with drafting the manuscript.

Corresponding author

Correspondence to Constance Guille.

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Ethics Approval

The study was approved by the Medical University of South Carolina Institutional Review Board (Protocol: 00052361).

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The informed consent process included written consent from participants.

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Not applicable.

Conflict of Interest

The authors declare no competing interests.

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Cite this article

Shapiro, M., Sujan, A.C. & Guille, C. A Clinical Trial of a Program for Pain Management and Opioid Reduction During Pregnancy. Reprod. Sci. 29, 606–613 (2022). https://doi.org/10.1007/s43032-021-00701-4

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  • DOI: https://doi.org/10.1007/s43032-021-00701-4

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