Buprenorphine with and without gabapentin and clonidine in detoxification of 5-16 year-old children with opioid use disorder: A randomized controlled trial

Background: The prevalence of opioid users is on the rise globally, and the city of Kerman, Iran, has a significant number of opioid use disorders. This issue extends beyond adults, as a considerable number of children and adolescents are also impacted. Objective: This study aims to evaluate the effectiveness of adding Clonidine and Gabapentin to Buprenorphine for inpatient detoxification of children and adolescents with opioid use disorders in the children's psychiatric ward of Shahid Beheshti Hospital in Kerman. Methods: This open randomised clinical trial was performed in 2021-2022. Forty patients aged 5 to 16 with opioid use disorder were divided into a control group treated with Buprenorphine and an intervention group treated with Buprenorphine plus Gabapentin and Clonidine. The severity of withdrawal symptoms was measured by the Clinical Opioid Withdrawal Scale and Subjective Opioid Withdrawal Scale before the intervention and every other day for 14 days. Results: 55% of patients were younger than 12. COWS and SOWS scores significantly decreased during the treatment course in both the case and control groups. However, the scores at different times, the dosage, and the duration of Buprenorphine use were not significantly different between the two groups. The mean dosage of Acetaminophen and Promethazine was lower in the intervention group and not statistically significant. Conclusions: Adding a combination of Gabapentin and Clonidine to Buprenorphine is not significantly superior to Buprenorphine alone in the detoxification of children and adolescents with opioid use disorder. We recommend a replication study with a larger sample size.