Maryhaven | Research

1. Stimulant Abuser Groups to Engage in 12 Step (STAGE 12): Evaluation of a Combined Individual-Group Intervention to Reduce Stimulant and Other Drug Use by Increasing 12-Step Involvement (CTN 0031)

The primary objective of this protocol is to evaluate the degree to which a combined group and individual 12-Step facilitative intervention, Stimulant Abuser Groups to Engage 12-Step (STAGE-12), improves substance-related outcomes compared to treatment as usual (TAU) without STAGE-12 among stimulant users.

2. Community Reinforcement and Family Training for Treatment Retention and HIV Risk Reduction (NIDA K23 Award)

Abstract: DESCRIPTION (provided by applicant): This K23 mentored patient-oriented research application will support the career development of the candidate in the areas of integrated behavioral and pharmacological therapies development for drug dependence treatment and long- term maintenance of recovery. Dr. Eugene Somoza of the University of Cincinnati will serve as the primary mentor. Dr. Natasha Slesnick of the Ohio State University and Dr. Robert Booth of the University of Colorado will serve as secondary mentors for behavioral therapies development and HIV risk behavior reduction respectively. In addition a team of accomplished investigators will serve as consultants to provide both training and supervision in specialized areas of the career development and research plans. The goal of the career development plan is to provide the candidate with the training and practical experience necessary to succeed as an independent investigator. The plan includes a range of mentor supervised activities including: 1) management of clinical trials, 2) publications and proposal writing, 3) attendance of graduate course work and professional seminars and, 4) the conduct of original research. The planned research will adapt a therapy of known efficacy to target a new outcome of significant importance to public health. The Community Reinforcement and Family Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to reinforcing treatment retention and HIV risk behavior reduction in persons with opioid dependence who receive a buprenorphine taper detoxification. The research plan includes three phases: 1) development of a manual guided therapy, 2) development of therapist training and fidelity measures and, 3) a randomized pilot with 52 patients receiving either the new CRAFT treatment or treatment as usual. Assessments will occur at baseline, end of treatment, 3 months and, 6 months. The primary outcome is retention in drug abuse treatment, specifically time to the opiate dependent person's first drop from services of 30 consecutive days. Secondary outcomes include: HIV risk behavior reduction, utilization of available treatment and, drug abuse. Opiate dependent individuals present a significant health risk to themselves and the public. With the recent approval of buprenorphine for drug abuse treatment, detoxification programs have become more effective at managing opioid withdrawal and transitioning patients to ongoing treatment. Following transfer to ongoing treatment retention rates decline and persons who return to opiate use are at high risk for direct negative consequences such as accidental drug over-dose and associated health risks such as HIV. Further improvements in treatment retention, maintenance of recovery and, HIV risk reduction are needed. This research and career development plan will lead to significant knowledge for improving treatment retention and reducing HIV risk behavior and, will prepare the candidate for a productive career as an independent patient-oriented clinical research scientist. UNIVERSITY OF CINCINNATI, SPONSORED RESEARCH SERVICES, CINCINNATI, OH 45221 Fiscal Year: 2008 Department: PSYCHIATRY Project Start: 01-SEP-2007 Project End: 30-JUN-2012 ICD: NATIONAL INSTITUTE ON DRUG ABUSE IRG: NIDA

(This information is taken from CRISP (Computer Retrieval of Information on Scientific Projects) which is maintained by the Office of Extramural Research at The National Institutes of Health (NIH))

3. Long Term Recovery Management (LTRM) - (NIDA Application Pending)

Abstract: DESCRIPTION (provided by applicant): Nicotine dependence continues to be the single most preventable cause of morbidity and mortality in the United States. Persons entering drug abuse treatment smoke at 3-4 times the rate, and staff in publicly funded programs smoke at twice the rate, of the general population. Although the burden of illness and associated economic costs of nicotine addiction are elevated in the drug treatment population, treatment programs rarely address comorbid nicotine addiction. While treatment programs increasingly recognize this paradox, there are few models available to guide them in nicotine dependence intervention. This study will test the effectiveness of the manualized Addressing Tobacco Through Organizational Change (ATTOC) intervention in facilitating the integration of drug abuse and nicotine dependence treatments. In a multiple baseline design with each program acting as its own control, three residential treatment programs will participate in a 6 month intervention designed to support organizational changes in nicotine policies, staff - level changes in nicotine knowledge, attitudes, practices, and client-level changes in exposure to and utilization of nicotine dependence treatment. At each measurement point (pre-intervention, post-intervention, and follow-up), a longitudinal sample of 50 agency staff will complete surveys concerning nicotine-related knowledge, attitudes and practices, and a cross-sectional sample of 50 agency clients will participate in phone surveys concerning nicotine-related services they have received. This work shifts the focus of nicotine dependence intervention from the person level to the organizational level, and tests the effectiveness of an organizational change intervention designed to address nicotine dependence. The investigative team unites the strengths of the UMDNJ intervention development team with those of the UCSF organizational change study team, in a context where both the intervention and the research procedures have been piloted. The study will be conducted on the NIDA CTN platform with the participation of nationally recognized and research-experienced treatment clinics. The short term goal is to test the effectiveness of the ATTOC intervention in addressing nicotine dependence among drug using persons in treatment. The long term goal is to develop and disseminate organizational change technologies that can be applied broadly, beyond nicotine dependence, to support programs in adopting evidence based practices.

Thesaurus Terms:
nicotine, attitude, base, clinical trial, dentistry, drug abuse, experience, health, measurement, medicine, model, school, shift work, smoking, tobacco, university, clinical research

Institution: UNIVERSITY OF CALIFORNIA SAN FRANCISCO3333 California St., Ste 315 SAN FRANCISCO, CA 941430962 Fiscal Year: 2008 Department: INSTITUTE FOR HEALTH POLICY STUDIES (IHPS) Project Start: 20-APR-2006 Project End: 31-MAR-2011 ICD:NATIONAL INSTITUTE ON DRUG ABUSE IRG:ZDA1

(This information is taken from CRISP (Computer Retrieval of Information on Scientific Projects) which is maintained by the Office of Extramural Research at The National Institutes of Health (NIH))

Abstract: DESCRIPTION (provided by applicant): The healthcare industry has staff turnover rates that are higher than any other industry. In particular, a recent national study of substance abuse treatment centers reports that the annual turnover rate among substance abuse counselors of 18.5% (Roman, Blum, & Johnson, 2002). Turnover renders direct (e.g., staff replacement costs) and indirect (e.g., lower quality patient care, loss of institutional knowledge) costs to substance abuse treatment centers and is a recognized problem in the field. The proposed project provides a comprehensive examination of turnover among substance abuse counselors and clinical supervisors, focusing on the effect that the clinical supervisory relationship has on the turnover of both parties. Both positive (i.e., benefits) and negative (i.e., costs) supervisory experiences are examined, from the perspective of both counselor and clinical supervisor, based on the growing recognition that clinical supervisory relationships can yield benefits as well as costs for both parties. Specific aims of the research are to: (1) examine the predictors of turnover among substance abuse counselors and clinical supervisors, (2) explore the mediating role of work attitudes (e.g., burnout, job satisfaction, commitment) in the relationship between clinical supervision and turnover, (3) track changes in the counselor-clinical supervisor relationship over time it develops and/or deteriorates, demonstrating how changes in the relationship predict career and work attitudes, as well as turnover, and (4) examine the role of counselor and clinical supervisor experience as it relates to turnover and other study variables. Counselor-clinical supervisor dyads will be studied over time in a longitudinal study of turnover. This project responds to program announcement PA-03-011 "Services Research in the National Drug Abuse CTN". Substance abuse treatment centers that are affiliated with the Clinical Trails Network will provide data for the project.

Thesaurus Terms:
substance abuse related disorder, attitude, base, birth, career, clinical trial, comprehensive care, drug abuse, emotion, employee, experience, health, human, income, industry, job satisfaction, medicine, model, motivation, occupation, patient care, role, clinical research

Institution: UNIVERSITY OF GEORGIA (UGA) Office of Sponsored Programs ATHENS, GA 306027411 Fiscal Year: 2008 Department: PSYCHOLOGY Project Start: 15-SEP-2006 Project End: 30-APR-2011 ICD:NATIONAL INSTITUTE ON DRUG ABUSE IRG:ZDA1

(This information is taken from CRISP (Computer Retrieval of Information on Scientific Projects) which is maintained by the Office of Extramural Research at The National Institutes of Health (NIH))

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. Subjects were either inpatient or outpatient in community treatment settings; however 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.

(This information is taken from PubMED which is maintained by the National Library of Medicine (NLM))

The U.S. Federal Food and Drug Administration approved buprenorphine for drug abuse treatment in 2002, and it became available for clinical use in early 2003. Maryhaven, a community treatment program, participated in a National Institute on Drug Abuse Clinical Trials Network trial evaluating buprenorphine-naloxone (BNX; Suboxone) short-term taper for medically managed opioid withdrawal 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.

(This information is taken from PubMED which is maintained by the National Library of Medicine (NLM))

AIMS: The clinical effectiveness of buprenorphine-naloxone (bup-nx) and clonidine for opioid detoxification in in-patient and out-patient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network. DESIGN: Diagnostic and Statistical Manual version IV (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 in-patients (77 bup-nx, 36 clonidine) and 231 out-patients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures guided by a self-help handbook. The criterion for treatment success was 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%) in-patients assigned to the bup-nx condition achieved the treatment success criterion compared to eight of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) out-patients assigned to the bup-nx condition achieved the treatment success criterion, compared to four of the 74 (5%) assigned to clonidine. CONCLUSION: 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.

(This information is taken from PubMED which is maintained by the National Library of Medicine (NLM))

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 16 mg 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.

(This information is taken from PubMED which is maintained by the National Library of Medicine (NLM))

7. Adult ADHD and Smoking Cessation Trial (CTN 0029) � The primary objective of this trial was to evaluate the efficacy of Osmotic Release Methylphenidate (OROS-MPH) and standard smoking treatment (i.e. nicotine patch and individual smoking cessation counseling), relative to placebo and standard smoking treatment, in achieving prolonged abstinence in smokers with ADHD. This was a multisite clinical trial with 6 sites participating.

A substantial number of women who enter substance abuse treatment have a history of trauma and meet criteria for posttraumatic stress disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. This study explored adverse events related to the implementation of an integrated treatment for women with trauma and substance use disorder (Seeking Safety) compared with a nontrauma-focused intervention (Women's Health Education). Three hundred fifty-three women enrolled in community substance abuse treatment were randomized to 1 of the 2 study groups and monitored weekly for adverse events. There were no differences between the two intervention groups in the number of women reporting study-related adverse events (28 [9.6%] for the Seeking Safety group and 21[7.2%] for the Women's Health Education group). Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse psychiatric and substance abuse symptoms. More research is needed on the efficacy of such interventions to improve outcomes of PTSD and substance use.

(This information is taken from PubMED which is maintained by the National Library of Medicine (NLM))

9. NIDA RO1 Treatment Development Application (forthcoming) � Dr. Brigham and Dr. Slesnick (OSU)

Addressing smoking in community drug abuse treatment programs: practical and policy considerations. Brigham GS, Schroeder G, Schindler E.

Smoking is the leading cause of preventable death in the United States. This public health problem is of particular concern among individuals with substance use disorders in that they smoke at a greater rate than the general public. Smoking-related illness represents a major source of preventable death in persons with drug dependencies. Substance abuse treatment programs have access to persons with substance use disorders and the opportunity to intervene on their smoking; however, nicotine dependence has historically not been viewed in the same light as other drug dependencies by the treatment field. As a result, many persons in these treatment program settings do not receive opportunities to address their smoking. When substance abuse treatment organizations consider implementing smoking policies and services, many questions and choices arise. In practice, a range of approaches has been developed from simple assessment and referral for smoking cessation treatment to implementing smoke-free grounds and requiring that patients stop smoking concurrent with addressing their other drug dependencies. Smoking cessation policy decisions have the potential to directly affect the patients, the workforce, the referral network, and other major stakeholders related to these organizations. The authors consider a range of both practical and policy issues facing treatment organizations and conclude that advances in smoking policy are possible with current resources.

(This information is taken from PubMED which is maintained by the National Library of Medicine (NLM))

Maryhaven, a comprehensive, community-based drug abuse treatment facility, combines a core commitment to 12-step principles and practices with the use of scientifically derived treatment interventions. Treatment goals at Maryhaven include abstinence from substance abuse, patient engagement and progress in 12-step activities, and strong patient affiliation with 12-step organizations within the community. The author discusses the reasons why Maryhaven takes this approach, describes the program's use of empirically derived treatment tools to further 12-step objectives, argues that there are natural affinities between 12- step and some empirical treatment tools such as the Stages of Change model, and suggests research projects that he believes can improve treatment and illuminate the mechanisms by which 12-step activities help patients overcome addiction.
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(This information is taken from NIDA which is a part of The National Institute of Health (NIH))

Abstract: DESCRIPTION (provided by applicant): The Ohio Valley Node (OVN) joined NIDA's Clinical Trials Network (CTN) four years ago, as one of the CTN's second wave of grantees. From the very beginning, the OVN has been a highly effective, enthusiastic, and energetic node that has excelled in providing scientific and administrative leadership, in collaborating with other nodes and with NIDA staff, and in disseminating information about evidence-based practice and the results of CTN studies. Moreover, the OVN has developed a model bi-directional relationship between its University of Cincinnati-affiliated Regional Research and Training Center (RRTC) and its six original ("core") community treatment programs (CTPs), which are located in Ohio, Indiana, Kentucky, and West Virginia. In this continuation application, the OVN proposes to enhance the geographical and cultural diversity of the CTN by expanding the OVN's Midwestern and Appalachian presence in the network and adding a Mississippi Delta component, via nine additional "protocol-specific" CTPs in five additional states. The fifteen OVN CTPs, which together treat more than 52,000 patients a year, will contribute significantly to the number and variety of potential participants for CTN studies. Each of the core OVN CTPs has participated in at least one CTN clinical trial and two survey studies and all six will continue to share in the administration of the node and in its development of research concepts and protocols. Although the new protocol-specific CTPs will play a more limited role, they are looking forward with enthusiasm to participating in appropriate clinical trials, providing an expanded and enriched patient population to the CTN. During the OVN's first four years in the CTN, we have immersed ourselves fully in all of its activities. We have submitted nine protocol concepts, of which five were chosen for further development; two have been converted into full protocols, including one which is currently enrolling participants. We have been active in the national committees of the CTN, providing five committee chairs and authoring or contributing to many SOPs and "guidance" documents. Unique contributions by the OVN include a system used CTN-wide for monitoring and reporting on staff training requirements and accomplishments, a system for tracking the progress of CTN clinical trials, and a template used to standardize the organization of CTN node budgets. The sense of satisfaction we feel in these and other accomplishments, together with the urgency we feel to continue working on the important search for effective treatments for substance abuse, make us eager to continue the work we have begun.

Thesaurus Terms:
cocaine, community health service, disulfiram, drug abuse chemotherapy, drug addiction, human therapy evaluation, alcoholism /alcohol abuse, clinical trial, cooperative study, therapy compliance , clinical research, health services research tag, human subject, patient oriented research