Effectiveness of Subdermal Buprenorphine Implants in Maintaining Opioid Abstinence
Treating opioid dependence with pharmacological agents.
As rates of opioid prescriptions have quadrupled in the US in recent years, opioid dependence has become an increasingly pressing public health issue.1 In addition to the associated risk of death from overdose, it has also been linked with the spread of infectious diseases.2,3
These problems decrease when opioid dependence is treated with pharmacological agents, which have been shown to be more effective in reducing illicit opioid use compared with psychosocial approaches.4 However, some patients may not adhere well to daily treatment with sublingual buprenorphine, and there is a general need in the field to explore strategies that may facilitate long-term remission of opioid dependence.
In a double-blind, double-dummy, randomized clinical trial recently published in JAMA, researchers at Icahn School of Medicine at Mount Sinai in New York and the University of Kentucky College of Medicine in Lexington investigated whether subdermal buprenorphine implants would maintain abstinence from illicit opioids in patients who had been on maintenance treatment with daily sublingual buprenorphine.5
The 26-week study took place at 21 buprenorphine outpatient treatment centers in the US and included 177 adult patients who had been taking sublingual buprenorphine for a minimum of 24 weeks at a dosage of 8mg/d or less. For inclusion, patients had to show no indications of withdrawal or illicit use within the previous 90 days. They were randomized to either daily sublingual buprenorphine at the same pre-study dosage combined with 4 placebo implants, or to daily placebo tablets combined with 4 active implants.
Assessments were conducted after the first week and then once monthly throughout the study period. During monthly visits, urine samples were collected (they were also collected 4 times at random), individual counseling was provided, and medication adherence was evaluated. Follow-up was conducted by phone at 1 week post-treatment and in person at 2 weeks post-treatment. Treatment was considered efficacious in study participants who had not taken illicit opioids for at least 4 of the 6 months the study lasted. Opioid use was assessed with urine test and self-report composites.
The findings show that 96.4% of patients in the active implant group were responders, compared with 87.6% of the sublingual buprenorphine group. The difference on the primary end point was 8.8% (1-sided 97.5% confidence interval, 0.009 to ∞; P < .001 for noninferiority; P = .03 for superiority). The implant group was also more likely to remain abstinent from months 3 through 6 of the study.
While further research involving broader populations is needed, these results suggest that buprenorphine implants could help improve relapse prevention in patients who are currently maintaining abstinence with sublingual buprenorphine.
- Centers for Disease Control and Prevention. Number and age-adjusted rates of drug-poisoning deaths involving opioid analgesics and heroin: United States, 2000-2014. Available at: http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning involving_OA_Heroin_US_2000-2014.pdf. Accessed July 27, 2016.
- Suryaprasad AG, White JZ, Xu F, et al. Emerging epidemic of hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-2012. Clin Infect Dis. 2014; 59(10):1411-1419.
- Conrad C, Bradley HM, Broz D, et al; Centers for Disease Control and Prevention. Community outbreak of HIV infection linked to injection drug use of oxymorphone—Indiana, 2015. MMWR Morb Mortal Wkly Rep. 2015; 64(16):443-444.
- Connery HS. Medication-assisted treatment of opioid use disorder: review of the evidence and future directions. Harv Rev Psychiatry. 2015; 23(2):63-75.
- Rosenthal RN, Lofwall MR, Kim S, Chen M, Beebe KL, Vocci FJ. Effect of buprenorphine implants on illicit opioid use among abstinent adults with opioid dependence treated withsublingual buprenorphine: a randomized clinical trial. JAMA. 2016; 316(3):282-290.