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- – Explain the regulatory interpretation of “prisoner” under 45 CFR 46;
- – Explain permissible categories of research at 45 CFR 46.306, and the Epidemiological Waiver;
- – Describe requirements for a prisoner representative and IRB review;
- – Describe the requirements for certification, the process of certification, and the necessary contents of a certification package.
- Download slides (pdf)
To date, the National Drug Abuse Clinical Trials Network Starting Treatment with Agonist Replacement Treatment Study (START) includes the largest database of patients (n=1269) entering opioid agonist treatment programs at community methadone centers around the United States (U.S.). Participants in the study were randomized to either Methadone (MET) treatment or Buprenorphine/Naloxone (BUP/Nx) treatment, and closely monitored during induction as well as throughout active treatment and follow-up. Pharmacotherapy was provided for 24 weeks with taper or continuation possible through week 32. Primary outcomes showed low rates of liver injury and no differences in liver functions between MET and BUP/Nx groups. Secondary findings present a multitude of interesting and clinically relevant outcomes. This Blending Initiative workshop presented several of those secondary outcomes from both a U.S. and international perspective.
Session One: United States Perspective
This segment of the session presented several important secondary outcomes from the START study including: From a comparison of the impact of MET vs. BUP/Nx treatment on HIV risk behaviors; a description of six different BUP/Nx and three different MET induction trajectories and their outcomes; and an association between genotype and treatment outcome in African-American participants receiving BUP/Nx or MET.
Session Two: International Perspective
To complement the findings and dissemination strategies from the U.S. perspective, a panel of international collaborators presented findings from studies conducted abroad and implementation strategies that have been successful. Presentations included outcomes from a collaborative project between NIDA and treatment providers in Indonesia, data from epidemiological studies showing the association between the length of MET treatment and mortality rates and dissemination and implementation strategies, and the use of incentive-based interventions in reducing drug use and associated consequences. The session also described the N-ALIVE (NALoxone InVEstigation) study–a large, prison-based, trial that assesses the number of lives that could be saved by providing Naloxone-on-release to adult prisoners with a history of heroin injection. The discussion after session two focused on on how the knowledge gained from these analyses and findings can be translated for the implementation of relevant MET or BUP/Nx treatment in clinical settings treating opioid dependent patients in the U.S. as well as internationally
Related protocols: CTN-0027
This presentation, part of a panel at the Society for Clinical Trials annual meeting in 2012 focusing on ethical, regulatory, recruitment issues in vulnerable populations, covers the basic definitions and guidelines for including participants who are considered “prisoners” in substance abuse treatment research. In order to conduct research with prisoners, there are several additional, potentially complex steps that must be undertaken with the researchers’ institutional review board of record. Used as a practical example, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders,” is discussed, as approximately 35% of participants at baseline were either mandated or referred for treatment by the criminal justice system (a handful even wearing monitoring bracelets). In any trial, regardless of whether you have approval to conduct research with prisoners, the study must have procedures in place to determine if a participant is indeed a prisoner. Though this can be straightfoward if the participant is in a detention facility, there are a small number of cases where participants reside in the community but are considered a prisoner under the definition of the Office of Human Research Protections (OHRP). For CTN-0044, this mean the development of a screening procedure that asked a simple question about house arrest and followed-up with additional probes if necessary (for participants in this protocol, even those wearing ankle monitors were not officially considered “prisoners” because while their movements were restricted, they were allowed to come and go of their own accord to the treatment facility). The presentation provides an in-depth look at the issues surrounding research with prisoners, including the importance of including individuals who become incarcerated during a study to reduce bias.
Related protocols: CTN-0044
This one-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, discusses the Office for Human Research Protection (OHRP) requirements regarding the use of prisoner populations in research. Viewers will receive clarification on applying for and implementing OHRP prisoner certification, its necessity in CTN trials, and specific requirements if OHRP prisoner certification is not obtained. Additional discussion regarding the OHRP definition of “engagement in research” will assist in determining if non-core study staff qualify under that classification.
The target audience is CTN members and other researchers and clinicians involved in research activities for new protocols that may involve the use of prisoner populations.
Presented by Robert Lindblad, MD and Jack Chally, MBA, EMMES Corporation.
Additional Resources:
- Download slides (pdf)