Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Brief Summary: CTN-0051 assesses 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 is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid).

The primary goal of the study is to estimate the difference, if 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. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, 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.


Options:
A: Arm Label: Probuphine; Type: EXPERIMENTAL; Interventions: Drug: Probuphine (buprenorphine implant) | Arm Label: placebo implant; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo implant | Arm Label: sublingual buprenorphine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Buprenorphine | Intervention Type: DRUG; Name: Probuphine (buprenorphine implant); Assigned to Arm(s): Probuphine | Intervention Type: DRUG; Name: placebo implant; Assigned to Arm(s): placebo implant | Intervention Type: DRUG; Name: Buprenorphine; Assigned to Arm(s): sublingual buprenorphine
B: Arm Label: 1-week buprenorphine taper; Type: EXPERIMENTAL; Interventions: Drug: buprenorphine taper followed by naltrexone maintenance, Behavioral: Behavioral therapy | Arm Label: 2-week buprenorphine taper; Type: EXPERIMENTAL; Interventions: Drug: buprenorphine taper followed by naltrexone maintenance, Behavioral: Behavioral therapy | Arm Label: 4-week buprenorphine taper; Type: EXPERIMENTAL; Interventions: Drug: buprenorphine taper followed by naltrexone maintenance, Behavioral: Behavioral therapy | Intervention Type: DRUG; Name: buprenorphine taper followed by naltrexone maintenance; Assigned to Arm(s): 1-week buprenorphine taper, 2-week buprenorphine taper, 4-week buprenorphine taper | Intervention Type: BEHAVIORAL; Name: Behavioral therapy; Assigned to Arm(s): 1-week buprenorphine taper, 2-week buprenorphine taper, 4-week buprenorphine taper
C: Arm Label: Interim Buprenorphine Treatment; Type: EXPERIMENTAL; Interventions: Drug: Interim Buprenorphine Treatment (IBT) | Arm Label: Waitlist Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Interim Buprenorphine Treatment (IBT); Assigned to Arm(s): Interim Buprenorphine Treatment
D: Arm Label: Extended-Release Naltrexone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Extended-Release Naltrexone | Arm Label: Buprenorphine-Naloxone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Buprenorphine-Naloxone | Intervention Type: DRUG; Name: Extended-Release Naltrexone; Assigned to Arm(s): Extended-Release Naltrexone | Intervention Type: DRUG; Name: Buprenorphine-Naloxone; Assigned to Arm(s): Buprenorphine-Naloxone

Answer: D