Division
HEAL Study
Title
Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. – an Adaptation of CTN-0032
Short Description
A randomized study to assess the relative effectiveness and cost-effectiveness of 1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. 2) on-site HIV rapid testing with information only in individuals seeking medical or health services at STD clinics.
Release Date
Jul 03, 2014
Description

This was a randomized, controlled trial in which 5012 participants seeking medical or health services from nine STD clinics were enrolled in a study comparing 1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. 2) on-site HIV rapid testing with information only. The purpose of this study was to explore whether the provision of counseling reduced risk behavior and sexually transmitted infections over time. In addition to HIV, participants were screened for sexually transmitted infections at the baseline visit and the 6-month follow-up visit.

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Division
HEAL Study
Investigator(s)
Title
HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
Short Description
To evaluate the more effective strategy to increase receipt of HIV test results and decrease sexual risk behaviors that lead to HIV transmission and acquisition among individuals receiving drug treatment within community-based drug abuse treatment programs in the United States.
Release Date
Nov 02, 2011
Description

This was a randomized, controlled clinical trial in which 1,281 adults receiving drug abuse treatment were recruited from 12 sites to participate in an HIV testing and counseling study. The purpose of this study was to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study also assessed the effectiveness of the three testing strategies in reducing HIV risk behaviors. Injection drug risk behavior was also assessed.

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Division
HEAL Study
Title
An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers
Short Description
An ancillary study to CTN-0031 to replicate the finding that performance on the STROOP color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with methamphetamine use disorders.
Release Date
Nov 26, 2013
Description

This was an ancillary study to CTN-0031, a randomized controlled trial of Stimulant Abuser Groups to Engage in 12-Step (STAGE-12). 219 participants from 3 sites who were randomized in the CTN-0031 study were eligible for the ancillary study, in which neurocognitive testing was performed and a blood sample was obtained for the assessment of oxidative stress/damage. The purpose of the ancillary study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with methamphetamine use disorders. The study also evaluated performance on additional neurocognitive measures and the level of oxidative damage and the impact of each of these on stimulant use outcomes.

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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.

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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.

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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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