Predictors of buprenorphine-naloxone dosing in a 12-week treatment trial for opioid-dependent youth: Secondary analyses from a NIDA Clinical Trials Network study.

This article reports on an ancillary investigation of protocol CTN-0010 (“Buprenorphine/Naloxone-Facilitated Rehabilitation for Opioid Dependent Adolescents/Young Adults”) examining baseline patient characteristics to predict dosing of buprenorphine-naloxone, a promising treatment for opioid addiction in youths. Outpatients aged 15-21 were randomized to a 12-week buprenorphine-naloxone dosing condition (including 4 weeks of taper) as part of CTN-0010. Predictors of dosing included sociodemographic characteristics (gender, race, age, and education), substance use (alcohol, cannabis, cocaine, and nicotine use), and clinical characteristics (pain and withdrawal severity). Most (75.4%) reported having either “some” (n=40, 58%) or “extreme” (n=12, 17.4%) pain on enrollment. Maximum daily dose of buprenorphine-naloxone (19.7mg) received by patients reporting “extreme” pain at baseline was significantly higher than the dose received by patients reporting “some” pain (15mg) and those without pain (12.8mg). In the adjusted analysis, only severity of pain and withdrawal significantly predicted dose. During the dosing period, there were no significant differences in opioid use, as measured by urinalysis, by level of pain.

These data suggest that the presence of pain in this population may be quite prevalent and also appears to predict buprenorphine-naloxone dose levels in opioid-dependent youth. Patients with pain have comparable opioid use outcomes to those without pain, but require higher buprenorphine-naloxone doses. Further research is needed to assess the clinical importance of pain preceding vs. following opioid use. This study further suggests that patients with pain respond to higher buprenorphine doses; hence, buprenorphine may have a role in managing pain in opioid-dependent youth.

Related protocols: CTN-0010