Division
HEAL Study
Investigator(s)
Title
Osmotic-Release Methylphenidate (OROS-MPH) for ADHD in Adolescents with Substance Use Disorders
Short Description
The main study objective was to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.
Release Date
Oct 04, 2010
Description

Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use 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.

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Division
HEAL Study
Investigator(s)
Title
Starting Treatment with Agonist Replacement Therapies (START)
Short Description
The primary objective of this study was to compare changes in liver enzymes related to treatment with buprenorphine/naloxone to changes in liver enzymes related to treatment with methadone in the outpatient setting during 24 weeks of treatment in participants meeting DSM-IV criteria for opioid dependence.
Release Date
Jun 06, 2012
Description

This was a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization was stratified, within site, according to normal versus abnormal eligibility assessment phase liver tests (LT) and participants received either BUP/NX or MET using a 2:1 allocation ratio. Participants meeting entry criteria were dosed for 24 weeks during the active phase of the study with assessment of liver function and injury at weeks 1, 2, 4, 8, 12, 16, 20, 24 and with follow-up assessments at week 32. A total of 1,269 participants were enrolled across eight sites.

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Deidentification Notes
Division
HEAL Study
Title
Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse
Short Description
To compare a Spanish version of MET to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment.
Release Date
Jul 30, 2008
Description

Because Spanish-speaking drug users are often not included in studies of drug abuse treatment, little is known about what works with this population. On the other hand, there is research that shows that this minority group carries attitudes and beliefs about substance abuse that may be barriers to participation in substance abuse treatment. A few studies do indicate, however, that efforts to motivate substance-abusing Hispanics can be effective in bringing them into treatment. One such intervention, Motivational Enhancement Therapy (MET), is a promising intervention that may increase Hispanic clients’ commitment to change and reduce their resistance to entering treatment. This study compares a three-session Spanish version of MET to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment.

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Division
HEAL Study
Investigator(s)
Title
Job Seekers Training for Patients with Drug Dependence
Short Description
To study the effectiveness of a 12-hour basic job-training program designed to give drug-dependent patients the skills they need to find and secure a job and set vocational goals and methods for locating employment.
Release Date
Feb 27, 2009
Description

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 do not 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.

Keywords
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Division
HEAL Study
Investigator(s)
Title
Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment
Short Description
To study a program for women in drug abuse treatment designed to build safer sexual skills and reduce unprotected sexual risk behavior.
Release Date
Oct 28, 2008
Description

Women in drug-using communities are one of the fastest growing groups of people with AIDS in the U.S. Female drug users, even if they are in drug treatment, are at especially high risk for heterosexual transmission of HIV. First, they are often in primary sexual relationships with male drug users. Second, like their male peers, some continue to use drugs despite being in treatment. When under the influence of drugs, especially cocaine or crack, they are more likely to engage in unprotected sex. It has been shown that drug abuse treatment can reduce activities related to drug use that increase the risk of HIV transmission. Sexual risk behaviors have received less attention, however, than those directly related to drug use. This study looks at a program for women in drug abuse treatment designed to build safer sexual skills and reduce unprotected sexual risk behavior. The program includes five sessions of group treatment that focus on assessing HIV risk, HIV safer sex problem solving, condom use, negotiation skills, and assertiveness training. This program will be compared to one session of HIV education, which is typically provided as standard care in drug treatment clinics.

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Division
HEAL Study
Investigator(s)
Title
Patient Feedback: A Performance Improvement Study in Outpatient Addiction Treatment
Short Description
To study whether feeding back performance data to clinic staff will improve patient attendance and abstinence.
Release Date
Aug 01, 2007
Description

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.

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Division
HEAL Study
Investigator(s)
Title
Women's Treatment for Trauma and Substance Use Disorders
Short Description
This study compares the effectiveness of two manualized interventions for women when added to treatment as usual: (1) Seeking Safety, a substance abuse treatment designed specifically for women with trauma and (2)Women’s Health Education, a psychoeducational program focused on health topics of special relevance for women.
Release Date
May 01, 2009
Description

Post-traumatic stress disorder (PTSD) is common among drug users, particularly among women. Those who suffer from both of these conditions also struggle more with both conditions and have a more difficult time meeting their treatment goals. Estimates also suggest that as many as 80% of women seeking treatment for drug abuse report lifetime histories of sexual and/or physical assault. These facts highlight the importance of finding effective treatments for this high-risk population. Early studies show Seeking Safety, a substance abuse treatment designed specifically for women with trauma, is an option with great potential for this population. This study compares the effectiveness of two manualized interventions for women when added to treatment as usual: Seeking Safety, and Women’s Health Education, a psychoeducational program focused on health topics of special relevance for women.

Keywords
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Division
HEAL Study
Investigator(s)
Title
Brief Strategic Family Therapy (BSFT) For Adolescent Drug Abusers
Short Description
This study was designed to compare BSFT to treatment as usual (TAU) in reducing adolescent drug use.
Release Date
Mar 02, 2010
Description

Adolescent drug abuse continues to be one of the most pressing public health issues in the United States—our nation’s teenagers continue to use illicit drugs at a worrisome rate. Broad reviews of the treatment outcome literature indicate that family interventions in general, and Brief Strategic Family Therapy (BSFT) in particular, are effective with drug using youth. This study was designed to compare BSFT to treatment as usual (TAU). The researchers believed that BSFT would be much more effective than TAU in reducing adolescent drug use.

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Division
HEAL Study
Investigator(s)
Title
Motivational Enhancement Therapy (MET) to Improve Treatment Utilization and Outcome in Pregnant Substance Users
Short Description
This study compares Motivational Enhancement Therapy (MET)with standard treatment in both alcohol and drug-using women.
Release Date
May 27, 2008
Description

About 5% of women use illicit substances during pregnancy, and approximately 22% of these also report using tobacco or alcohol. A number of treatment programs have started to offer treatment specifically designed for pregnant substance abusers. While these programs have shown some success, it is still difficult to keep these women in treatment. Brief motivational sessions have been found to improve treatment engagement and outcomes in both alcohol and drug using women. This study compares one such treatment intervention, Motivational Enhancement Therapy (MET), with standard treatment. The three individual MET sessions focus on developing rapport, exploring perceived pros and cons of using substances, reviewing the participant’s feedback on the consequences of substance use and the status of her pregnancy, and developing a change plan or strengthening the commitment to change. Patients assigned to standard treatment receive the treatment normally given in that clinic; this will include at least three individual sessions that are also designed to help them overcome alcohol and drug use.

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Division
HEAL Study
Title
Characteristics of Screening, Evaluation, and Treatment of HIV/AIDS, Hepatitis C Viral Infections, and Sexually Transmitted Infections in Substance Abuse Treatment Programs
Short Description
The study surveys CTP administrators and direct care providers to review available services for infectious disease in substance abuse treatment programs.
Release Date
Jun 11, 2007
Description

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

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Study Data
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Protocol
Case Report Form(s)