Study 31 – Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT); CTN-0051

Ancillary Study: Contribution of Specified Opioid Receptor Gene Variants to Outcome of Extended Release Naltrexone vs. Buprenorphine/Naloxone Treatment for Opioid Dependence

Investigators:  John Rotrosen, M.D. (NYU Langone Medical Center); Ancillary Study: Mary Jeanne Kreek, M.D. (Rockefeller University)

Status:  Available at dbGaP

Abstract:  For opioid-dependent patients in the U.S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment.  Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications.

The overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact.  To this end, CTN-0051 will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

The study will be conducted in approximately 8 CTN-affiliated CTPs that provide detoxification services (inpatient/residential), have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide mediation-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period.  Approximately 400 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks.  To maximize generalizability, the point of randomization will be flexible, from shortly after program admission until just prior to program discharge.  A study design modification (a shift to a later point of randomization) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i.e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction).

The primary goal of the study is to estimate the difference, of one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e., loss of persistent abstinence) during the 6-month trial.  The primary outcome measure will be the time to the event, with the event called relapse.  Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, (2) explore demographic, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.

Toward the end of the 24-week treatment period, participants will be referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes will be assessed at week 28 and week 36 after randomization.  For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study will provide a two-week BUP-NX taper (beginning at the week 24 visit).

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