Division
HEAL Study
Title
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
Short Description
To evaluate the degree to which a combined group and individual 12-Step facilitative intervention, Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), improves substance-related outcomes compared to treatment as usual (TAU) without STAGE-12 among stimulant abusers.
Release Date
Feb 06, 2012
Description

This was a randomized, controlled clinical trial in which 471 stimulant abusers were recruited from 10 sites to participate in study comparing 12-Step (STAGE-12) plus treatment as usual (TAU) to TAU alone. The purpose of this study was to evaluate reduction in percent of days of stimulant use as measured by self-report. The study also evaluated reduction in percent days of use of other substances, the degree to which STAGE-12 increased involvement in 12-step activities and attendance at 12-step meetings, and the extent to which such 12-step involvement and meeting attendance mediated substance use outcomes.

Keywords
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Division
HEAL Study
Title
Long-Term Follow-Up to CTN-0030 (A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Individual Drug Counseling for Opioid Analgesic Dependence)
Short Description
An ancillary study to CTN-0030 to examine long-term outcomes for individuals with opioid analgesic dependence.
Release Date
Aug 22, 2014
Description

This was an ancillary study to CTN-0030, a two-phase randomized controlled clinical trial of buprenorphine/naloxone treatment plus individual drug counseling for opioid analgesic dependence. All participants (648) randomized to Phase 1 of the CTN-0030 study were eligible for the ancillary study. Participants were assessed via telephone at 1.5, 2.5, and 3.5 years post-Phase 1 randomization into the CTN-0030 study. The study evaluated opioid use, quality of life, and pain.

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Division
HEAL Study
Title
A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Individual Drug Counseling for Opioid Analgesic Dependence
Short Description
To determine whether the addition of individual drug counseling to the prescription of buprenorphine/naloxone and Standard Medical Management improves outcome.
Release Date
Jun 22, 2011
Description

Patients with prescription opioid dependence may be able to benefit from pharmacological treatments shown to be effective in heroin addicts. Clinical research has established BUP as a safe and effective alternative to methadone. The primary objective of this study is to determine whether the addition of individual drug counseling to the prescription of buprenorphine/naloxone along with Standard Medical Management 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.

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Division
HEAL Study
Title
A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers with ADHD
Short Description
The main study objective was to evaluate whether OROS MPH compared to placebo increases the effectiveness of standard smoking treatment in obtaining prolonged abstinence for smokers with ADHD.
Release Date
Dec 15, 2009
Description

Adult ADHD is a common and impairing neuro-psychiatric disorder, affecting approximating seven to eight millions adults in the United States. Substance use disorders, including cigarette smoking and nicotine dependence, are some of the more common co-morbid disorders with adult ADHD. Studies have found that adults with ADHD are twice as likely to smoke cigarettes and be dependent on nicotine than adults without ADHD.

Keywords
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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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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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