Extended-release injection vs sublingual buprenorphine for illicit opioid use in pregnant patients with depression and/or anxiety.

Background: Active depression and/or anxiety (D/A) symptoms among pregnant individuals with opioid use disorder (OUD) may impact the efficacy of new OUD medication treatment formulations.

Methods: We conducted an exploratory secondary analysis of an intent-to-treat, parallel group, randomized trial that compared the effectiveness of injectable extended-release buprenorphine (XR-BUP) to sublingual (SL-BUP). Participants included pregnant adults (N=140) seeking or receiving buprenorphine for OUD treatment. A total of 52.1% (n=73) of participants screened positive for active D/A symptoms at baseline, assessed using the Hospital Anxiety and Depression Scale. The primary outcome of illicit opioid abstinence, measured by urine drug screens, was assessed from baseline through one-year postpartum. We also assessed buprenorphine adherence, opioid craving, and withdrawal during the same period. We employed descriptive statistics to characterize baseline population characteristics and longitudinal multiple regression to test treatment effects across time.

Results: Opioid abstinence during pregnancy was higher in the XR-BUP group than the SL-BUP group who were D/A positive (group difference=12.5%, p=0.03) compared to D/A negative (group difference=6.7%, p=0.27). Withdrawal was lower during the postpartum period in the XR-BUP group than the SL-BUP group for those D/A positive (group difference −2.9, p<0.01) compared to those D/A negative (group difference= −0.7, p=0.47). We observed a time effect for decreases in the proportion of participants who were D/A positive during pregnancy (Odds Ratio=0.27, p<0.01).

Conclusions: Among pregnant individuals with OUD and co-occurring D/A symptoms, XR-BUP may confer greater benefits related to opioid abstinence and reduced withdrawal symptoms compared to SL-BUP.

Related protocols: CTN-0080