Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence, current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an alarming number of clinics have extensive waitlists for treatment slots. Patients can remain on these waitlists for years, placing them at elevated risk for illicit drug use, criminal activity, infectious disease, overdose and mortality during this period. These delays in treatment access represent a significant barrier to the widespread delivery of effective opioid treatment, and there is a critical need to develop creative new approaches for mitigating these delays. Our overarching goal in this application is to develop a novel Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our integrative treatment package includes five key components, each strategically chosen to maximize patient access to pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth clinical support delivered via Interactive Voice Response, Automated random call-backs for urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants who have not entered treatment by Week 12 will be offered the opportunity to cross over to IBT at that time, contributing additional within-subject data with which to evaluate the efficacy of the IBT intervention. The proposed research is innovative in several important ways: By facilitating the eradication of waitlists for opioid treatment, it represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment of opioid dependence is conceptualized and delivered. The IBT components are highly novel, both individually and as an integrative interim treatment package for opioid dependence. This study will be the first to investigate the utility of IBT in the patients and settings that stand to benefit most from it. The investigators also propose a multi-pronged dissemination approach that will ensure that our work is readily transported to clinical practice and will have a direct impact on real-world treatment of opioid dependence. Taken together, the proposed project will produce a highly innovative technology-assisted pharmacotherapy protocol that can be widely disseminated to increase access to life-saving opioid treatment. The overarching and specific aims of this proposal are directly relevant to NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse treatment.


Options:
A: Arm Label: Methadone; Type: OTHER; Interventions: Drug: Methadone | Arm Label: Buprenorphine/Naloxone; Type: OTHER; Interventions: Drug: Buprenorphine-Naloxone | Intervention Type: DRUG; Name: Methadone; Assigned to Arm(s): Methadone | Intervention Type: DRUG; Name: Buprenorphine-Naloxone; Assigned to Arm(s): Buprenorphine/Naloxone
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methadone | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Buprenorphine/naloxone | Intervention Type: DRUG; Name: Methadone; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Buprenorphine/naloxone; Assigned to Arm(s): 2
C: Intervention Type: DRUG; Name: buprenorphine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: naltrexone; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: behavior therapy; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: voucher-based contingency management; Assigned to Arm(s): N/A
D: 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

Answer: D