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The focus of this presentation is on the outcomes of medication studies in the CTN and how those outcomes can be applied to treatment in community-based settings. Medication studies in the CTN have included four studies on opioid dependence (buprenorphine vs. clonidine, buprenorphine taper, buprenorphine for adolescents, and the Prescription Opioid Addiction Treatment Study) and two studies on methylphenidate (methylphenidate for smokers with ADHD and methylphenidate for adolescents with ADHD and substance use disorder). Outcomes from each trial are presented, along with implications for community-based treatment providers. Overall, these protocols have demonstrated that medication studies — both straight-forward studies and highly complex ones — can be conducted safely and effectively in community drug abuse treatment programs. Staff members in these programs can be highly enthusiastic about the new therapies, something that aids in implementation, and evidence supports the fact that successful medication trials can lead to increased use of empirically validated pharmacotherapies.
The presentation ends with a look at ongoing and future medication research in the CTN, including buprenorphine for cocaine dependence, long-acting injectable naltrexone for opioid dependence, bupropion for smokers with stimulant dependence, buspirone for cocaine dependence, and treatments for cannabis dependence.
Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0009, CTN-0010, CTN-0028, CTN-0030
This presentation describes the growth and diverse characteristics of the CTN community treatment provider network (CTPs), a network that began with only 52 participants in 2000 is has now grown to 187 in 2010. CTPs in the CTN typically fall into one of two categories: those offering medication-assisted treatments (methadone/harm reduction) and those that do not (“drug free” clinics). To date, there have been ten medication-based trials in the CTN, 6 involving Suboxone, 2 involving methylphenidate, and 1 each using nicotine patches and bupropion.
The presentation describes many of these protocols, focusing in particular on the impact participation in medication-assisted treatment trials has had on CTP use of agonist replacement medications in general. The positive outcomes of such participation are described, as well as considerations for future research.
This presentation provides an overview of the CTN protocols that examined various pharmacotherapies for opiate dependence (buprenorphine/naloxone, e.g.), smoking cessation, and adolescents.
Each protocol is described, along with its aims and conclusions, and the presentation ends with a “to-do list” for future CTN pharmacotherapy research, in the hopes that protocols about cocaine, methamphetamine, marijuana, pharmacogenetics, combination therapies (medication plus behavioral treatments), and comorbidity will be explored down the line.
Related protocols: CTN-0001, CTN-0002, CTN-0003, CTN-0009, CTN-0010, CTN-0027, CTN-0028, CTN-0029, CTN-0030
For individuals dependent on opioids, recovery efforts begin with a period of withdrawal that typically includes discomfort from symptoms, possibly precipitating a return to drug use. The study described here, a secondary analysis of individuals enrolled in the National Drug Abuse Treatment Clinical Trials Network study CTN-0002 (“Buprenorphine/Naloxone versus Clonidine for Outpatient Opiate Detoxification”), investigated whether the provision of ancillary medications for opioid withdrawal symptoms affected treatment outcomes in 139 participants receiving buprenorphine in a 13-day detoxification trial. Outcomes measures include the number of opioid-free urine samples collected and retention in treatment. Ancillary medications were provided to 70% of participants: 59% received medication for insomnia, 45% for anxiety, 40% for bone pain, 35% for nausea, and 28% for diarrhea.
Findings indicate no difference in the number of opioid-free urine samples between the group receiving ancillary medication and the group who did not, although tests of specific ancillary medications indicate that those who received diarrhea medication had fewer opioid-free urines than those who did not (P = .004). Results also indicate that participants attended fewer days of treatment if they received anxiety, nausea, or diarrhea medication compared to no medication (all P values < .05). Clinicians treating individuals dependent on opioids should consider high rates of craving and withdrawal symptoms and the need for ancillary medications as a red flag for further monitoring and assessment. Practice changes that may be required include adjusting buprenorphine dose, increasing provision of ancillary medications, switching to another pharmacotherapy, or providing alternatives to medication for treating withdrawal symptoms, and monitoring patients to ensure they are taking buprenorphine as instructed.
Related protocols: CTN-0002
Few studies in community settings have evaluated predictors, mediators, and moderators of treatment success for medically supervised opioid withdrawal treatment. This report presents new findings about these factors from a study of 344 opioid-dependent men and women prospectively randomized to either buprenorphine-naloxone or clonidine in an open-label 13-day medically supervised withdrawal study (protocols CTN-0001 and CTN-0002, “Buprenorphine/Naloxone versus Clonidine for Inpatient/Outpatient Opiate Detoxification”). Subjects were either inpatient or outpatient in community treatment settings, but were not randomized by treatment setting. Medication type (buprenorphine-naloxone versus clonidine) was the single best predictor of treatment retention and treatment success, regardless of treatment setting. Compared to the outpatient setting, the inpatient setting was associated with higher abstinence rates but similar retention rates when adjusting for medication type. Early opioid withdrawal severity mediated the relationship between medication type and treatment outcome with buprenorphine-naloxone being superior to clonidine at relieving early withdrawal symptoms. Inpatient subjects on clonidine with lower withdrawal scores at baseline did better than those with higher withdrawal scores; inpatient subjects receiving buprenorphine-naloxone did better with higher withdrawal scores at baseline than those with lower withdrawal scores. No relationship was found between treatment outcome and age, gender, race, education, employment, marital status, legal problems, baseline depression, or length/severity of drug use. Tobacco use was associated with worse opioid treatment outcomes. Severe baseline anxiety symptoms doubled treatment success. Medication type (buprenorphine-naloxone) was the most important predictor of positive outcome; however the paper also considers other clinical and policy implications of other results, including that inpatient setting predicted better outcomes and moderated medication outcomes.
Related protocols: CTN-0001, CTN-0002
This session of the 2008 NIDA Blending conference featured three presentations about Buprenorphine. The first, by Thomas Freese, is entitled, “Buprenorphine Treatment: A Training for Multidisciplinary Addiction Professionals.” It describes the NIDA/SAMHSA Blending Initiative, and provides an overview of the Addiction Technology Transfer Centers and the CTN. Additionally, it provides a brief history of Buprenorphine and the effects of chronic opioid use. The second half of the presentation focuses on the use of Buprenorphine in the treatment of opioid addiction, studied in two CTN protocols, CTN-0001 and CTN-0002 (Buprenorphine-Naloxone vs. Clonidine for Short-Term Inpatient/Outpatient Opiate Detoxification).
The second presentation of this session, by Mary Ann Detmer, briefly describes the three phases of buprenorphine treatment: induction, stabilization, and medically supervised withdrawal.
The final presentation, by Gregory S. Brigham, is about “Adopting Buprenorphine-Naloxone Short-Term Taper for Medically Managed Opioid Withdrawal.” It describes the process undertaken when Maryhaven, a CTP in the Ohio Valley Node that participated CTN-0001, decided to implement Buprenorphine short-term taper for their patients after the study was completed. It addresses the importance of ongoing monitoring, evaluation, and feedback on provider modifications and interventions.
Related protocols: CTN-0001, CTN-0002
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
Buprenorphine-naloxone (BNX) tablet treatment for opioid dependence became available for clinical use in the U.S. in January 2003. Before BNX approval, a large randomized clinical trial of short-term use of BNX for medically supervised withdrawal from opioids was completed by the NIDA Clinical Trials Network (protocol CTN-0001, “Buprenorphine/Naloxone versus Clonidine for Inpatient Opiate Detoxification”). Maryhaven, a community treatment provider, had a favorable experience in the study and decided to use a similar short-term BNX treatment for withdrawing patients from opioids over 2 to 3 weeks. This presentation utilizes results from a retrospective chart review to describe their research-to-practice experience and clinical outcomes from 64 opioid-dependent patients enrolled in Maryhaven’s BNX programming, which includes direct, residential induction onto 8-32 mg of BNX followed by tapering doses and transfer to additional short-term residential care or supervised ambulatory detoxification. Patients are encouraged to continue with treatment beyond the BNX taper. Most patients (84%) completed the BNX taper and also engaged in treatment beyond detoxification. The BNX taper completion rate represents a substantial improvement over the historical 56% completion rate of clonidine detoxification available before the BNX program. While these patient outcomes were impressive ongoing feedback was required to maintain the treatments effectiveness when shorter tapers were found to be effective at managing withdrawal but not at facilitating continued treatment. Since detoxification alone is not an effective treatment for opiate dependence, it is possible to improve detoxification completion rates without improving treatment.
This presentation describes the adoption of a scientifically proven efficacious treatment by community treatment provider and will highlight the need for ongoing evaluation and feedback to guide the adaptation of the intervention, maintain targeted outcomes and, provide continued incentives to maintain the new practice.
The U.S. Federal Food and Drug Administration approved buprenorphine for drug abuse treatment in 2002, and it became available for clinical use in 2003. Maryhaven, a community treatment program, participated in National Institute on Drug Abuse Clinical Trials Network trial CTN-0001, evaluating buprenorphine-naloxone (BNX, Suboxone) short-term taper for medically managed opioid withdrawal in inpatient clinics, and later adopted this treatment.
In a retrospective review, the first 64 patients treated with a BNX taper were compared with two groups of patients treated with clonidine before and after the implementation of the BNX program. Significantly more patients (about 80%) receiving BNX continued in further treatment compared to about 30% of those receiving clonidine. Patient outcomes are discussed in the context of the critical need for treatment continuation following detoxification. Common questions of potential adopters of the BNX taper are presented and addressed. Overall, BNX was readily integrated into the existing treatment service.
Related protocols: CTN-0001
AIMS: The clinical effectiveness of buprenorphine-naloxone (bup-nx) and clonidine for opioid detoxification in inpatient and outpatient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network.
DESIGN: DSM-IV-diagnosed opioid-dependent individuals seeking short-term treatment were randomly assigned, in a 2:1 ratio favoring bup-nx, to a 13-day detoxification using bup-nx or clonidine.
METHODS: A total of 113 inpatients (77 bup-nx, 36 clonidine) and 231 outpatients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures defined as the proportion of participants in each condition who were both retained in the study for the entire duration and provided an opioid-free urine sample on the last day of clinic attendance. Secondary outcome measures included use of ancillary medications, number of side effects reported and withdrawal and craving ratings.
FINDINGS: A total of 59 of the 77 (77%) inpatients assigned to the bup-nx condition achieved the treatment success criterion compared to 8 of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) outpatients assigned to the bup-nx condition achieved the treatment success criterion, compared to 74 (5%) assigned to clonidine.
CONCLUSIONS: The benefits of bup-nx for opioid detoxification are supported and illustrate important ways in which clinical research can be conducted in community treatment programs.
Correction published in Addiction 2006;101(9):1374 names the members of the Buprenorphine Study Protocol Group Steering Committee as follows: Walter Ling, Joan Muir-Malcolm, Eugene Somoza, Edward Nunes, Charles Shuster, John Rotrosen, Dennis McCarty, George Woody, Nancy Waite-O’Brien, Debbie Orr, Greg Brigham, Betty Buchan, Terry Horton, Susan Stine, Steven Ruth, Larry Brown, Robert Maslansky, David Smith, Brad Anderson, Steven Fekete, and Douglas Ziedonis. It also adds Susan M. Stine from Wayne State University to the list of acknowledgements.
Related protocols: CTN-0001, CTN-0002
This brochure, intended for participants thinking about joining the CTN-0010 (Buprenorphine/Naloxone-Facilitated Rehabilitation for Opioid Dependent Adolescents/Young Adults) study, provides an overview of the project and two medications and answers any questions participants might have about being involved.
Related protocols: CTN-0010
This brochure, intended for participants in the CTN-0010 (Buprenorphine/Naloxone-Facilitated Rehabilitation for Opioid Dependent Adolescents/Young Adults) study, provides an overview of what the project entails and answers any questions participants might have about being involved.
Related protocols: CTN-0010
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
This brochure, intended for participants in the CTN-0001 and CTN-0002 clinical trials (Buprenorphine/Naloxone for Opiate Detoxification – Inpatient and Outpatient), describes the study and provides information on reporting symptoms, medical monitoring, and using birth control.
Related protocols: CTN-0001, CTN-0002