Division
HEAL Study
Investigator(s)
Title
Assessment of the National Drug Abuse Clinical Trials Network: A Baseline for Investigating Diffusion of Innovation
Short Description
Using a series of surveys, this study will be help to understand the Community Treatment Programs participating in the NIDA Clinical Trials Network (CTN).
Release Date
Jan 25, 2007
Description

The "Baseline Study" is designed to help us better understand the community treatment programs participating in the NIDA Clinical Trials Network (CTN). Using a series of surveys, the study will be used to:

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Study Data
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Division
HEAL Study
Investigator(s)
Title
Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics
Short Description
To study treatment incentives, interventions that can motivate clients to attend treatment sessions and initiate and sustain abstinence, compared to treatment outcomes in methadone-based Community Treatment Programs.
Release Date
Dec 13, 2006
Description

To improve treatment outcomes, it is necessary to use interventions that can motivate clients to attend treatment and initiate and sustain abstinence. Extensive research has consistently shown that client motivation for positive behavioral change can be influenced by the use of novel interventions based on established behavioral principles. In numerous controlled experimental studies in both outpatient cocaine treatment and methadone maintenance programs, procedures involving the provision of tangible incentives (prizes, coupons, vouchers, e.g.) to clients for drug-free urines resulted in sustained periods of abstinence and retention in treatment. This study in methadone-based Community Treatment Programs (CTPs) will utilize incentive values that are considerably lower in cost than those typically used in research clinics.

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Study Data
Study Links
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Division
HEAL Study
Investigator(s)
Title
Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics
Short Description
To study treatment incentives, interventions that can motivate clients to attend treatment sessions and initiate and sustain abstinence, compared to treatment outcomes in Community Treatment Programs.
Release Date
Oct 31, 2006
Description

To improve treatment outcomes, it is necessary to use interventions that can motivate clients to attend treatment and initiate and sustain abstinence. Extensive research has consistently shown that client motivation for positive behavioral change can be influenced by the use of novel interventions based on established behavioral principles. In numerous controlled experimental studies in both outpatient cocaine treatment and methadone maintenance programs, procedures involving the provision of tangible incentives to clients for drug-free urines resulted in sustained periods of abstinence and retention in treatment. The initial study in Community Treatment Programs will utilize incentive values considerably lower than those typically used in research clinics.

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Division
HEAL Study
Investigator(s)
Title
MI (Motivational Interviewing) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse
Short Description
To evaluate the efficacy of one session using Motivational Interviewing techniques (MI), relative to a standard treatment intake interview. The primary outcome measure is retention in treatment and reduction of drug use during and post-treatment.
Release Date
Sep 08, 2006
Description

This study aims to evaluate the efficacy of Motivational Interview (MI) techniques, relative to a standard treatment intake interview at participating CTPs, in enhancing treatment engagement and retention as well as in reducing substance use. It will also evaluate the durability of MI relative to standard treatment at CTPs through a 3 month follow-up. Secondary aims of this study are to explore patient characteristics associated with outcome, to evaluate the ability of clinicians at the CTPs to learn and effectively implement MI techniques, and to conduct process analyses which will assess and evaluate multiple aspects of this treatment approach.

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Division
HEAL Study
Investigator(s)
Title
MET to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse
Short Description
To compare three therapy sessions using Motivational Interviewing (MI) techniques versus standard treatment. The primary outcome measure is retention in treatment and reduction of drug use during and post-treatment.
Release Date
Oct 03, 2007
Description

Early dropout, partial attendance, and early relapse are common occurrences in most substance abuse treatment programs. Because the bulk of attrition occurs very early in treatment and retention in treatment has been linked to better outcomes, identifying effective, practical means of enhancing initial treatment engagement and outcome is an important target for the Clinical Trials Network. Motivational Enhancement Treatment (MET) is a systematic intervention approach based on the principles of motivational psychology that utilize motivational strategies to mobilize the client's own change resources. A considerable body of research for more than two decades has shown strong support for the usefulness of motivational interventions in initiating treatment and in reducing use of alcohol, cigarettes, and abused drugs. This protocol will test the therapeutic usefulness of incorporating MET into the standard drug abuse treatment entry process of Community Treatment Programs on improving treatment engagement, retention, and outcome.

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Division
HEAL Study
Investigator(s)
Title
Suboxone (Buprenorphine/Naloxone) Taper: A Comparison of Two Schedules
Short Description
To compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.
Release Date
May 29, 2008
Description

For decades clinicians have been frustrated by the inability to successfully detoxify opiate addicted patients because opiate-based detoxification, one of the most effective means to achieving that goal, has been unavailable outside the very restrictive confines of narcotic treatment programs (NTPs). A new medication, buprenorphine, shows promise as an effective aid for opiate detoxification. However, little data have been generated for the shorter-term use of buprenorphine/naloxone for this indication. This protocol will compare the clinical utility of two dosage tapering regimens in buprenorphine/naloxone stabilized subjects for opiate detoxification.

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Division
HEAL Study
Investigator(s)
Title
Buprenorphine/Naloxone versus Clonidine for Outpatient Opiate Detoxification
Short Description
To test the utility of Buprenorphine/Naloxone in short term (13 day) detoxification versus Clonidine in an outpatient setting.
Release Date
Jul 26, 2006
Description

For decades clinicians have been frustrated by the inability to successfully detoxify opiate addicted patients because opiate-based detoxification, one of the most effective means to achieving that goal, has been unavailable outside the very restrictive confines of narcotic treatment programs (NTPs). A new medication, buprenorphine, shows promise as an effective aid for opiate detoxification. However, little data have been generated for the shorter-term use of buprenorphine/naloxone for this indication. Since the diversity of clinics in the CTN provides an unparalleled opportunity to conduct such a clinical endeavor, the utility of buprenorphine/naloxone in short term (13 day) detoxification versus clonidine in an outpatient setting will be tested in the CTN.

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Study Data
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Division
HEAL Study
Investigator(s)
Title
Buprenorphine/Naloxone versus Clonidine for Inpatient Opiate Detoxification
Short Description
To test the utility of Buprenorphine/Naloxone in short term (13 day) detoxification versus Clonidine in an inpatient setting.
Release Date
May 08, 2006
Description

For decades clinicians have been frustrated by the inability to successfully detoxify opiate addicted patients because opiate-based detoxification, one of the most effective means to achieving that goal, has been unavailable outside the very restrictive confines of narcotic treatment programs (NTPs). A new medication, buprenorphine, shows promise as an effective aid for opiate detoxification. However, little data have been generated for the shorter-term use of buprenorphine/naloxone for this indication. Since the diversity of clinics in the CTN provides an unparalleled opportunity to conduct such a clinical endeavor, the utility of buprenorphine/naloxone in short term (13 day) detoxification versus clonidine in an inpatient setting will be tested in the CTN.

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Division
HEAL Study
Investigator(s)
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Modafinil For Methamphetamine Dependence
Short Description
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence.
Release Date
Sep 02, 2015
Description

The primary objective of this study is to assess the efficacy of modafinil in increasing the number of methamphetamine non-use weeks in subjects with methamphetamine dependence

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Division
HEAL Study
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Topiramate For The Treatment Of Methamphetamine Dependence
Short Description
The objectives of this study are to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
Release Date
Sep 02, 2015
Description

The primary efficacy objective of this study is to determine if topiramate relative to placebo reduces methamphetamine use in subjects with methamphetamine dependence as measured by quantitative urinalysis for methamphetamine. The primary efficacy outcome measure is negative methamphetamine use weeks during study Weeks 6 through 12. Data collected during this phase of treatment will be the focus of the primary outcome measure as this is the time period in which the subject will be treated with the maintenance dose of topiramate.

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