Is there enough naloxone to deter the diversion? Effect of concurrent administration of intravenous naloxone on opioid agonist effects of intravenous buprenorphine: A randomised, double‐blind, within‐subject, crossover study among opioid‐dependent subjects

• Published in: Drug and alcohol review 2020-07, Vol.39 (5), p.595-603
• Main Authors: Dhagudu, Naveen K., Ambekar, Atul, Agrawal, Alok, Rao, Ravindra, Mishra, Ashwani K., Jain, Raka, Singh, Shalini
• Format: Article
• Language: English
• Subjects: abuse‐deterrent formulation; Acknowledgment; Buprenorphine; Dosage; Double-blind studies; Drug abuse; Drug diversion; Euphoria; Informed consent; Intravenous drugs; intravenous substance abuse; Liking; Methadone; Naloxone; Narcotics; opiate substitution treatment; Opioids; Sedation
• ISSN: 0959-5236; 1465-3362
• DOI: 10.1111/dar.13057

Introduction and Aims We aimed to evaluate and compare the effect of different intravenous doses of naloxone on reinforcing effect of intravenous buprenorphine (2 mg) in patients stabilised on sublingual buprenorphine. Design and Methods This is a double‐blind, within‐subject, randomised, crossover study. Opioid‐dependent patients, with history of intravenous drug use, stabilised on buprenorphine maintenance treatment were included after informed consent (n = 14). We administered and assessed the reinforcing effects of six test conditions: buprenorphine and naloxone co‐formulation (BNX) in 4:1, 2:1 and 1:1 dose ratio (i.e. buprenorphine 2 mg + naloxone 0.5, 1 and 2 mg, respectively), buprenorphine alone (2 mg), pheniramine maleate (45.5 mg) and saline at 24 hourly intervals. Results No significant opioid withdrawals were precipitated during any test conditions. Compared to buprenorphine alone, 4:1 BNX had comparable euphoria, drug recognition, subjective opiate sensations and drug liking (P > 0.05); 2:1 BNX condition had significantly different subjective euphoria (P = 0.001), opioid recognition (P = 0.002), subjective opioid sensations at 60 min (P = 0.027) and drug liking (P