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This study, supported in part by a CTN Invest Fellowship awarded to the first author, aimed to assess the prevalence of non-opioid drug use among opioid-addicted buprenorphine injecting individuals in Georgia (former Soviet republic), during and after a 12-week course of buprenorphine-naloxone (Suboxone) or methadone. This randomized, controlled trial used daily observed Suboxone or methadone and weekly counseling, urine tests, and Timeline Followback (TLFB) in weeks 0-12, and 20, as well as the Addiction Severity Index (ASI) at weeks 0, 4, 8, 12, and 20. Of the 80 patients (40/group, 4 women), 68 (85%) completed the 12 weeks of study treatment and 66 (82.5%) completed the 20 week follow-up.
At baseline, injecting more than one drug in the last 30 days was reported by 68.4% of patients in the methadone and 72.5% in the Suboxone groups. Drug use was markedly reduced in both treatment conditions, but there were significant differences in the prevalence of specific drugs with more opioid (1.5 vs. 0.2%; p = 0.03), less amphetamine (0.2 vs. 2.8%; p < 0.001) and less marijuana (1.7 vs. 10.2%; p < 0.001) positive urine tests in the methadone vs. Suboxone groups. At the 20 week follow-up, TLFB results on the 34 that continued methadone or the 3 on Suboxone showed less opioid (5.6 vs. 27.6%; p < 0.001), illicit buprenorphine (2.7 vs. 13.8%; p = 0.005), benzodiazepine (13.5 vs. 34.5%; p < 0.001), and marijuana (2.8 vs. 20.7%; p < 0.001) use than the 29 who did not continue opioid substitution therapy.
Conclusions: Daily observed methadone or buprenorphine-naloxone therapy with weekly counseling was markedly effective in reducing not only opioid use, but use of other psychoactive substances in Georgia, though there was more non-opioid use in patients treated with Suboxone, and more opioid use in patients treated with methadone. As in other settings, stopping opioid substitution therapy was associated with relapse to non-prescribed and other drug use.
[Note: the CD version of this product is no longer available. Factsheets and links to additional resources may still be available at the link provided.]
This new CD-ROM features copies of the three previous buprenorphine-related Blending Products (Buprenorphine Treatment, Short-Term Opioid Withdrawal Using Buprenorphine, and Buprenorphine Treatment for Young Adults), bundled together with the new Prescription Opioid Addiction Treatment Study (POATS) product.
The new POATS product includes a clinician training program and manual, PowerPoint presentation, resource list, fact sheets, and additional materials to help clinicians implement and promote buprenorphine treatment in their practices.
This CD-ROM compilation includes resources in a variety of formats, including training manuals (PDFs), PowerPoint presentations, short video clips, research articles, and other resources.
Detoxification often serves as an initial contact for treatment and represents an opportunity for engaging patients in aftercare to prevent relapse. However, there is limited information concerning clinical profiles of individuals seeking detoxification, and the opportunity to engage patients in detoxification for aftercare often is missed. This study used data from protocols CTN-0001 and CTN-0002 to examine clinical profiles of a geographically diverse sample of opioid-dependent adults in detoxification to discern the treatment needs of a growing number of women and whites with opioid addiction and to inform interventions aimed at improving use of aftercare or rehabilitation. Gender and racial/ethnic differences in addiction severity, HIV risk, and quality of life were examined. Results found that women and whites were more likely than men and African Americans to have greater psychiatric and family/social relationship problems, and to report poorer health-related quality of life and functioning. White and Hispanics exhibited higher levels of total HIV risk scores and risky injection drug use scores than African Americans, and Hispanics showed a higher level of unprotected sexual behaviors than whites. African Americans were more likely than whites to use heroin and cocaine, and to have more severe alcohol and employment problems. These results highlight the need to monitor an increased trend of opioid addiction among women and whites and to develop effective combined psychosocial and pharmacologic treatments to meet the diverse needs of the expanding opioid-abusing population. Elevated levels of HIV risk behaviors among Hispanics and whites also warrant more research to delineate mechanism and reduce their risky behaviors.
Supported by the Duke Clinical Research Institute (CTN DSC 1).
Related protocols: CTN-0001, CTN-0002
As the Clinical Trials Network begins to focus efforts on disseminating the results of its research studies to the addiction treatment field, it is important to begin to assess the capacity of programs outside the CTN to integrate with fidelity these endorsed treatment practices. To date, no data exist to assess the representativeness of opioid treatment programs (OTPs) participating in the CTN, nor the potential barriers to the effective diffusion of practices aimed at the treatment of opioid dependent patients, including buprenorphine. Using data obtained from OTPs within the CTN (N=49) and a sample drawn from the population of U.S. OTPs (N=50), this study compares the two groups on their organizational, clinical, and client characteristics, as well as their adoption of buprenorphine.
The study finds that the populations differ significantly on numerous variables, but that structural characteristics appear more predictive of buprenorphine adoption than either staff or caseload differences. Implications for studying the diffusion and implementation of evidence-based research findings are discussed.
This session of the 2008 NIDA Blending Conference featured three presentations about the role of genetics in addiction treatment. The first, by Mary Jeanne Kreek, provides a detailed description of how addiction develops and the hypothesis that it is driven by an atypical responsivity to stressors that may be genetic in nature. An overview of the way genetics have been studied in the addiction field is also provided.
The second and third presentations, by Louise Haynes and Allan Cohen respectively, introduce a new CTN protocol, CTN-0027a (an adjunct to CTN-0027, “Starting Treatment with Agonist Replacement Therapies (START)”) called “START Pharmacogenetics: Exploratory Genetic Studies in Starting Treatment with Agonist Replacement Therapies.” This study will ask for volunteers participating in START to provide blood samples that will be examined for the frequency of gene variants that have primarily been associated with addiction. The “START Genetics” protocol is the first, but hopefully not the last, genetics study conducted within the CTN. Details of the study’s objectives and methods are included in Cohen’s presentation.
Related protocols: CTN-0027, CTN-0027-A-1
The National Institute on Drug Abuse’s Clinical Trials Network (CTN) aims to improve addiction treatment in the United States in part through technology transfer. Buprenorphine has been the subject of several multi-site clinical trials within the CTN. Two of these trials (CTN-0001 and CTN-0002) showed that buprenorphine was superior to clonidine for opiate detoxification in both inpatient and outpatient treatment settings. A third is examining different buprenorphine tapering schedules during opiate detoxification (CTN-0003), while a fourth is focused on the effectiveness of this medication in adolescents and young adults (CTN-0010).
Given the intense study of buprenorphine within the CTN, this pharmacological innovation offers an opportunity to examine larger organizational processes related to the diffusion of evidence-based treatment practices. This research draws on community-based treatment centers that are part of the larger National Treatment Center Study, a family of longitudinal studies examining changes in service delivery within the American specialty substance abuse treatment system. It compares the attitudes of 561 CTN-affiliated and 1,745 non-CTN-affiliated counselors toward buprenorphine. The data indicated a measurable difference in the perceived acceptability of buprenorphine as a treatment innovation, with CTN-affiliated counselors reported significantly greater acceptability than non-CTN counselors. This difference was not explained by controlling for counselor characteristics, but was completely attenuated by measures of buprenorphine-specific training and buprenorphine implementation.
Because the CTN’s impact on counselor attitudes may be attributed to the greater exposure to buprenorphine received by CTN-affiliated counselors, these data suggest that the benefits of clinical research being conducted in community-based treatment settings may extend beyond demonstrating the effectiveness of an intervention.
Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0010
Note: This product is no longer available.
Accelerating the dissemination of research-based drug abuse treatment findings into community-based practice is a key priority for NIDA and represents the core mission of the NIDA/SAMHSA Blending Initiative. This initiative is NIDA’s most recent and innovative effort to accelerate the dissemination of research-based drug abuse treatment findings into community-based practice. NIDA’s partnership with SAMHSA has led to the creation of Blending Teams, which are composed of members from SAMHSA’s Addiction Technology Transfer Center (ATTC) Network and NIDA researchers who have worked closely to collectively develop Blending Team Products. This set of CD-ROMs combines all five products developed through the NIDA/SAMHSA Blending Initiative into a single package: Buprenorphine Treatment: Training for Multidisciplinary Addiction Professionals; Short-Term Opioid Withdrawal Using Buprenorphine; Treatment Planning M.A.T.R.S: Utilizing the Addiction Severity Index (ASI) to Make Required Data Collection Useful; Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA:STEP); and Promoting Awareness of Motivational Incentives (PAMI).
Each of the disks contains training materials, PowerPoint presentations, and other resources needed to facilitate the adoption of science-based interventions in community settings. All of these materials are in the public domain and are inteded for wide dissemination. Copies of this CD set were sent to all Node PIs and Research Utilization Committee (RUC) representatives in Fall 2007.
Related protocols: CTN-0001, CTN-0002, CTN-0005, CTN-0006, CTN-0007
The NIDA Clinical Trials Network (CTN) blends the skill and experience of two key groups of experts in drug abuse treatment: community-based treatment providers and academic researchers. More than 240 community treatment programs (CTPs) are spread across the 17 CTN Nodes and comprise a diverse and extensive network of sites interested in developing and participating in a variety of research endeavors, including health services research projects. However, incorporating services research into a multi-site clinical trial is a complex process, regardless of whether the trial is in its earliest stages of development or has been in the field for some time.
This presentation describes the interdigitation of three different services research projects into CTN-supported clinical trials and highlights the specific demands inherent when this occurs at each of three stages in the host study’s progress: deployed in the field; in a late stage of development; or in an early, formative state. The first example describes protocol CTN-0030 (Prescription Opiate Abuse Treatment Study), which is examining the impact of two medication management models of varying expense and complexity for patients with opioid analgesic dependence. It had been in the field for over a year when the additional HSR project was proposed to conduct cost-effectiveness analyses, including the cost of incremental benefits if one model proves superior. The second example presents a trial to study the impact of rapid testing for HIV infection combined with a brief counseling intervention (CTN-0032, HIV Rapid Testing and Counseling). It was in its first stage of operational development when the additional HSR project was proposed to examine its cost-effectiveness. The third example describes a trial that examines a combined group/individual intervention to facilitate engagement of stimulant abusers into community-based 12-step groups (CTN-0031, Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)) . It had been in its final stages of operational planning when the HSR project was proposed to examine the impact of organizational characteristics at the CTP-level on the eventual implementation and adoption of the intervention after trial completion. This third scenario provides a close look at the intricate negotiations between the external HSR researchers and the scientists, research operation managers, statisticians, and database managers at the CTN study required to integrate the proposed HSR project smoothly and productively. The presentation concludes with descriptions of specific opportunities for other interested health services researchers to develop collaborative relationships with the CTN sites.
Related protocols: CTN-0030, CTN-0031, CTN-0032
Researchers and policymakers are increasingly focusing on factors that facilitate or impede the diffusion of evidence-based treatment techniques into routine clinical practice. One potentially fruitful avenue of research is the influence of involvement in research networks as a predictor of organizational innovation.
The Clinical Trials Network (CTN) is examining a number of behavioral and pharmacological treatment techniques in controlled multisite studies. Using data from participating CTN treatment programs and large samples of programs outside the CTN, these analyses examine the influence of exposure to clinical trials on the subsequent adoption of buprenorphine and voucher-based motivational incentives. The analyses show that, controlling for a variety of organizational characteristics, direct exposure to buprenorphine clinical trials in the CTN significantly increased the odds of subsequent adoption. By contrast, the adoption of motivational incentives was entirely explained by organizational characteristics.
The findings suggest that adoption of treatment innovations is a function of exposure, organizational resources, nature of innovations, and stage of the diffusion process.
Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0006, CTN-0007, CTN-0010
This presentation provides a detailed introduction to the use of buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone) in the treatment of opioid dependence. The presenter, Allan J. Cohen, is the director of one of the community treatment programs (CTPs) involved in the new CTN platform study, NIDA-CTN-0027, “Starting Treatment with Agonist Replacement Therapies (START),” a project that will compare the physical effects of buprenorphine with methadone.
In this presentation, Cohen describes in detail the various phases of buprenorphine treatment for opioid dependence and describes Subutex/Suboxone as safe, well-tolerated, effective, and clinically flexible medications with low abuse potential that can be used for maintenance or medically supervised withdrawal. Buprenorphine is also easily integrated into diverse settings (outpatient treatment, offices, hospitals, residential treatment, etc.), and has the potential for enhancing management of special populations. Cohen continues by briefly comparing buprenorphine with methadone and LAAM, and discussing training/education and cost issues related to the prescribing of Subutex and Suboxone.
Related protocols: CTN-0027
In 2002 tablet formulations of buprenorphine were approved by the FDA for the treatment of opiate addiction. The National Drug Abuse Treatment Clinical Trials Network (CTN) has implemented and completed two clinical trials comparing a short-term opioid withdrawal using buprenorphine versus clonidine in both inpatient and outpatient settings (protocols NIDA-CTN-0001 and NIDA-CTN-0002). The results of these trials suggest that buprenorphine is substantially better than clonidine for opioid detoxification.
|In order to prepare the field to effectively integrate this treatment method into their current practice, NIDA formed a Blending Team to develop this package of training materials to instruct providers on how to implement the procedures evaluated through these research protocols. This training was designed to provide a broad overview of the medication, its effects, and the role of non-physician practitioners in providing and supporting the treatment of individuals receiving this medication.
|The training package includes PowerPoint training slides, a Trainer’s Manual, and a marketing brochure. The training manual is designed to support a half-day face-to-face training to review the results from the CTN research protocols. It then provides instruction for implanting these protocols into treatment settings including methods of evaluation and induction, the taper schedule, and the use of ancillary medications during treatment. Adaptation of these materials to meet the needs of the specific target audience is expected and supported by the materials themselves (for example, detailed speaker notes, not a word-for-word script, are provided for maximum flexibility). The training requires approximately four hours, and trainers should plan to have a laptop, LCD projector, and flip chart paper or easel/white board on hand for the training.
Related protocols: CTN-0001, CTN-0002
The adoption of pharmacotherapies for the treatment of alcohol and drug use disorders has progressed slowly despite the approval of new and effective medications. This paper begins with overviews of the prevalence of alcohol and drug abuse and dependence, the costs of addiction to the nation, and the value of treatment services. The role of pharmacotherapy in the treatment of addictive diseases is examined, and factors that affect the adoption and use of medications for alcohol and drug treatment are identified and discussed. CTN protocols CTN-0001 and CTN-0002, testing the effectiveness of buprenorphine for treatment of opioid dependence in new settings, are used as examples to illustrate physician and counselor training and mentorship strategies that may promote the adoption of medications in the treatment of alcohol and drug use disorders. The paper concludes with a discussion of barriers and ways to surmount them and foster greater use of medications in alcohol and drug treatment.
Related protocols: CTN-0001, CTN-0002
The primary goal of this Blending Team product is to create awareness and build knowledge about buprenorphine among multidisciplinary addiction professionals. The materials include information designed to increase motivation for bringing buprenorphine to local communities, as well as information about what to expect when someone is treated with this medication. Additionally, materials discuss legislation that permits office-based buprenorphine treatment, the science of addiction, the mechanism of buprenorphine, patient selection issues, and various patient, counseling, and therapeutic issues.
The Buprenorphine Awareness Blending Team package contains: the Training Guide for the 6-hour training, an informational brochure about the product, and two CDs. The first CD contains the PowerPoint presentation for the training, electronic copies of the Training Guide and brochure, and a draft version of an annotated bibliography about Buprenorphine. The second CD contains a video entitled, “Put Your Smack Down! A Video about Buprenorphine” (used in Module VI of the training) and an online course developed by the Central East ATTC called “Buprenorphine Treatment of Opioid Addiction: A Guide for Counselors.” Each of these items can also be downloaded from the ATTC web site.
In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus.
Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.
Related protocols: NIDA-CTN-0001 , NIDA-CTN-0002
This brochure, intended for participants thinking about joining the CTN-0001 and CTN-0002 clinical trials (Buprenorphine/Naloxone for Opiate Detoxification – Inpatient and Outpatient), describes the study and provides and overview of the medications that will be used.
Related protocols: CTN-0001, CTN-0002