- In two pilot clinical trials, buprenorphine helped participants reduce their illicit opioid use and injection drug use while awaiting admission to a methadone or buprenorphine treatment program.
- Researchers minimized the risks for improper use or diversion of the study medication by giving it to trial participants in a computerized, tamper-proof device that dispenses one dose each day.
- Research staff monitored participants’ craving, withdrawal, drug use, and medication adherence with an interactive voice response system and random callbacks.
For most adults with opioid use disorder, maintenance therapy with methadone or buprenorphine is the most effective treatment approach. However, many who present to clinics offering such treatment are placed on waitlists for months. During this time, they are at high risk for continued drug use, overdose, death, criminal activity, infectious diseases, and other negative outcomes. Although studies have shown that interim methadone treatment can reduce drug use and associated risks during the waitlist period, regulatory and logistical challenges have hindered its wide implementation. Now, NIDA-supported researchers have developed an interim buprenorphine regimen and found it to be safe, effective, and potentially feasible in two small trials.
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Dr. Stacey Sigmon and colleagues at the University of Vermont used technology to provide waitlisted opioid users with controlled access to buprenorphine and support their abstinence with minimal clinical and administrative input. After a week of daily clinic visits in which the trial participants were inducted onto buprenorphine and their dosing requirements determined, each was issued a Med-O-Wheel Secure dispensing device stocked with a 2-week supply of buprenorphine/naloxone sublingual tablets (see Figure 1). The tamper-proof device was programmed to make each day’s dose available during a 3-hour time window. Each evening, participants were contacted via a phone-based interactive voice response (IVR) system and prompted to rate their opioid cravings and withdrawal symptoms and to report any use of opioids or other drugs. Once every other week, at random times, the IVR system also notified participants to report to the clinic for urine drug testing and progress monitoring. Participants could also contact the research staff between visits if they experienced difficulties with craving, withdrawal, or other problems.
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Dr. Sigmon and colleagues first tested their approach in a feasibility trial with 10 participants who had been using opioids, on average, for 8.4 years. Most primarily used prescription opioids, although 60 percent reported having used heroin at least once. After being stabilized on buprenorphine, 90 percent of participants provided urine samples that were negative for illicit opioids at 2 and 4 weeks, and 60 percent were abstinent at 8, 10, and 12 weeks. Whereas the participants reported using opioids on 29 days, on average, in the month before starting the trial, the seven who completed the trial reported using the drugs an average of 0.35 days during its final month. The participants also registered lower scores on the Addiction Severity Index at the end of the study, compared with their scores at intake. Completion of the IVR calls and random callbacks were high at 97 and 82 percent, respectively.
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In the subsequent larger trial, 25 waitlisted opioid-dependent adults were randomized to receive interim treatment with buprenorphine, and another 25 to remain in a waitlist control condition. Nearly 90 percent of the participants who received buprenorphine provided urine specimens that were free of illicit opioids at 4 and 8 weeks after induction, and nearly 70 percent at 12 weeks (see Figure 2). In contrast, no control participants provided illicit-opioid–negative specimens during the trial. The participants who received buprenorphine also reported significant reductions in frequency of illicit-opioid use and injection-opioid use, as well as in Addiction Severity Index scores (see Figure 3). Similar to the prior study, the patients who received buprenorphine responded to nearly all—96 percent—of both the IVR calls and the random callbacks.
Dr. Sigmon and colleagues will aim to replicate and extend these results in larger trials. Ultimately, they hope that their approach to helping treatment-seeking opioid users reduce risks while awaiting program admission will prove both beneficial and cost-effective.
These studies were supported by NIH grants DA037385, T32DA007242, and P20GM103644.
Sigmon, S.C., Meyer, A.C., Hruska, B., et al. Bridging waitlist delays with interim buprenorphine treatment: Initial feasibility. Addictive Behaviors 51:136-142, 2015. Full text
Sigmon, S.C., Ochalek, T.A., Meyer, A.C., et al. Interim buprenorphine vs. waiting list for opioid dependence. New England Journal of Medicine 375(25):2504-2505, 2016. Abstract
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NIDA (). Buprenorphine Benefits Waitlisted Seekers of Opioid Treatment. Retrieved , from https://www.drugabuse.gov/news-events/nida-notes/2017/03/buprenorphine-benefits-waitlisted-seekers-opioid-treatment