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CLINICAL UNIT BASED RESEARCH

Alcohol and Drug Abuse Treatment Program

Completed Protocols

CTN-0008
A Baseline for Investigating Diffusion of Innovation
Lead Node: Oregon Node
Lead Investigator: Dennis McCarty, Ph.D.
The 'Baseline Study" is designed to help better understand the community treatment programs participating in the NIDA Clinical Trials Network (CTN). Using a series of surveys, the goals of the study are to:

The researchers involved in this study understand the importance of a strong partnership between themselves and the treatment programs. This alliance can help the CTN build its own plan for promoting the use of proven, effective and innovative treatment methods.

CTN-0010
Buprenorphine/Naloxone-Facilitated Rehabilitation for Opioid Dependent Adolescents/Young Adults
Lead Node: Delaware Valley Node
Lead Investigator: George E. Woody, M.D.
The use of heroin and other opiates by American adolescents is at its highest level since the 1960s. However, the treatment of young heroin users has not been particularly effective, and some treatment providers are reluctant to use the medications they reserve for their older patients, especially for long-term opioid maintenance. This study compares two 3-month treatments for adolescents/young adults who are addicted to heroin. Both groups get 3 months of psychosocial treatment (individual and/or group drug counseling). In addition, one group, the experimental group, gets 3 months of buprenorphine stabilization. The control group is detoxified from opiates using buprenorphine over a 7 - 14 day period. The researchers believe the use of a 3-month stabilization with buprenorphine/naloxone in combination with psychosocial therapy will more effectively reduce heroin use, help these young people comply with their treatment, and improve their overall adjustment than brief detoxification with buprenorphine.

CTN-0012
Characteristics of Screening, Evaluation, and Treatment of HIV/AIDS, Hepatitis C Viral Infection, and Sexually Transmitted Infections in Substance Abuse Treatment Programs
Lead Node: New York Node
Lead Investigator: Lawrence S. Brown, Jr., M.D., M.P.H.
Substance abuse is associated with a wide spectrum of medical disorders, including infections due to the human immunodeficiency virus (HIV) and the hepatitis C virus (HCV) as well as sexually transmitted infections. Despite the seriousness of this problem, there has not been a systematic investigation of infectious disease services in the substance abuse treatment health care delivery system. This is a study of policies and services in Community Treatment Programs (CTPs) related to these infections. The study surveys CTP administrators and direct care providers and reviews policies related to clinical guidelines and reimbursement policies through a survey of administrators of state substance abuse agencies or health departments. In addition to filling the information gap about available services for infectious disease in substance abuse treatment programs, this study will provide a basis for later studies on the efficiency of these services and of health outcomes.

CTN-0016
Patient Feedback: A Performance Improvement Study in Outpatient Addiction Treatment
Lead Node: Delaware Valley Node
Lead Investigator: Robert F. Forman, Ph.D.
Although accrediting organizations, funding sources, and other agencies require community treatment providers to monitor performance, there are no studies showing that this is an effective practice or that it helps addiction treatment patients, clinicians, or managers. This study tests whether one such strategy, feeding back performance data to clinic staff, will improve patient attendance and abstinence. Ratings by patients of their group counseling experience, plus information on patient attendance and retention, will be reported to clinicians and program managers twice a month. Clinicians will receive reports for their caseload; managers will receive clinic-wide reports. Every month managers and clinicians will discuss the clinic-wide reports, identify opportunities for improvement, and make plans to increase the clinic-wide ratings. This study also measures the impact of the system on manager/clinician relations, staff job satisfaction, and whether clinicians and managers will continue to use the system after the study ends.

CTN-0017
HIV and HCV Intervention In Drug Treatment Settings
Lead Node: Rocky Mountain Region Node/Oregon Node
Lead Investigator: Robert Booth, Ph.D.
The connection between AIDS and drug injection is well established. Through June 2000, injection drug users accounted for more than a third of all cases reported among persons aged 13 or older to the Centers for Disease Control and Prevention. Hepatitis C virus (HCV), transmitted primarily through sharing drug preparation and injection equipment, is also a major public health concern. Sixty percent of HCV transmission is related to injection drug use and as many as 50-95% of injection drug users are infected with HCV. This study tests two strategies to reduce the risk of contracting HIV or HCV by reducing risk behaviors in patients undergoing drug detoxification. The first includes pre-test counseling, testing, post-test counseling, and the provision of HIV/HCV results. The second strategy, called therapeutic alliance, provides clients with information to guide them through the process of role induction and aims to facilitate transition to continuing care for drug treatment. Both will be compared to standard care in drug detoxification settings.

CTN-0020
Job-Seekers Training for Patients with Drug Dependence
Lead Node: Mid-Atlantic Node
Lead Investigator: Dace Svikis, Ph.D.
Drug abuse clients who are employed typically do better in their treatment than those who are unemployed. In addition, unemployment is a chronic problem in drug-dependent people. Despite the high rates of unemployment in this population, community treatment programs often don't have the resources to provide vocational services. This study will examine the effectiveness of a 12-hour basic job-training program designed to give patients the skills they need to find and secure a job and set vocational goals and methods for locating employment. The intervention to be evaluated is modeled after the Job Seekers' Workshop, which was manualized and has been tested in trials.

CTN-0028
Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity (ADHD) in Adolescents with Substance Use Disorders (SUD)
Lead Investigator: Paula Riggs, MD
Research shows a high prevalence of ADHD in adolescents with SUD and indicates that they have poorer substance treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood.  Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes.  The main objectives of this study are to evaluate the efficacy of OROS-MPH/Concerta, relative to placebo, in treating ADHD and decreasing substance use in Adolescents with ADHD and a substance use disorder (SUD).  Secondary objectives include: evaluating the safety and abuse liability of OROS-MPH in the treatment of adolescents with ADHD and a SUD; and evaluating the impact of treating ADHD with OROS-MPH on substance use treatment outcomes and psychosocial functioning. 

CTN-0029
A Pilot Study of Osmotic-Release Methylphenidate (OROS-MPH) in Initiating and Maintaining Abstinence in Smokers with Attention Deficit Hyperactivity Disorder (ADHD). 
Lead Node: Ohio Valley Node
Lead Investigator: Eugene Somoza, M.D., Ph.D.
Adult ADHD is a common psychiatric disorder, affecting approximately 7 to 8 million adults in the United States.  Substance use disorders, including cigarettes and nicotine dependence, are some of the more common co-occurring disorders with adult ADHD. Long-acting stimulants, such as sustained release methylphenidate are a mainstay of the treatment of adult ADHD.  Researchers posit that successful treatment of ADHD symptomatology will result in decreased cigarette abuse and potentially have large public health benefits.  There have been no known clinical trials of OROS-MPH for initiating and maintaining abstinence in smokers with ADHD previously conducted.  The primary objective of this study is to evaluate whether OROS-MPH, relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD.

CTN-0030
A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Individual Drug Counseling for Opioid Analgesic Dependence
Lead Node: Northern New England Node
Lead Investigator: Roger D. Weiss, M.D.
While opioids have been used for decades to treat chronic pain, serious concerns about prescription opioid abuse have increased in recent years.  Despite the increase in prescription opiate abuse, there is an unmet need to provide adequate treatment to patients addicted to prescription opioid drugs.  Developing a set of treatment guidelines and understanding the response to treatment among patients with prescription opioid dependence is a significant clinical priority.  The primary objective of this study is to determine whether the addition of individual drug counseling to the prescription of buprenorphine/naloxone (BUP/NX) along with Standard Medical Management (SMM) for subjects dependent on prescription opioid analgesics improves outcome both during a) an initial four-week treatment with taper and b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment with taper; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.

CTN-0044
Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders
Lead Node: Long Island Regional Node
Lead Investigator: Edward V. Nunes, PhD.
The principal objective of the planned trial is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA) intervention plus incentives targeting drug abstinence and treatment participation as part of community-based, outpatient substance abuse treatment. The trial will use NIDA’s Clinical Trials Network (CTN) platform, at approximately 10 Community Treatment Programs (CTPs), including Stanley Street Treatment & Resources, Inc. (SSTAR) in Fall River, Massachusetts. Participants randomized will receive 12 weeks of either: (1) Treatment-as-Usual (TAU), reflecting standard treatment at the collaborating CTPs in which participants are enrolled, or (2) a modification of TAU which includes access to the Therapeutic Education System (TES), a computerized psychosocial intervention which combines skills building modules based on the Community Reinforcement Approach with incentives contingent upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules.

CTN-0047
Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED): Evaluation of Screening, Brief Intervention, Referral to Treatment (SBIRT) and Booster Session for Drug Use Patients Presenting for Treatment in the Emergency Department
Lead Nodes: Southwest Node and Pacific Northwest Node
Lead Investigators:  Michael Bogenschutz, MD and Dennis M. Donovan, PhD
The present study builds on the knowledge base in developing and implementing screening and brief interventions for harmful and hazardous alcohol use delivered in emergency departments and trauma centers, by transferring and evaluating these procedures when applied to drug use.  The study will contrast substance use and substance-related outcomes among patients endorsing problematic substance use during an emergency department (ED) visit who are randomly assigned to one of three treatment conditions:  1) minimal screening only (MSO); 2) screening, assessment, and referral to treatment (if indicated) (SAR); and 3) screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster sessions (BI-B).  The primary outcome is days of use of the patient-defined primary problem drug at 3 months following enrollment.  Secondary outcomes include change from baseline in days of use of the primary substance, the number days abstinent from all drugs, days of heavy drinking, total quantity of drug use, objective change in drug use based on analysis of hair samples, self-reported consequences of drug and alcohol use, percent entering treatment among those classified as having probable dependence, and ED and other health care utilization.  The study is being conducted locally at the Massachusetts General Hospital Emergency Department.

Current Protocols

CTN-0049
Project HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
Lead Nodes: Florida Alliance Node and Western States Node
Lead Investigator: Lisa R. Metsch, PhD
Project HOPE will evaluate the effectiveness of a brief intervention delivered to HIV-infected drug users recruited from the hospital setting in achieving viral suppression.  The trial comprises:  1) an active patient navigator component:  a strengths-based case management approach that includes motivation, physical escort to treatment, and face-to-face booster sessions; and 2) a passive incentives/contingency management component to further motivate and reinforce completion of target behaviors.  The primary goal of the study is HIV viral suppression.  In addition, the study will also determine linkage and retention in HIV primary care, linkage and retention in drug abuse treatment, and reduction in numbers of hospitalizations.  This study is taking place locally at Boston University Medical Center.

11.2013