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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Division
HEAL Study
Title
A Multicenter Safety Trial of Buprenorphine/Naloxone for the Treatment of Opiate Dependence
Short Description
To determine if the 4:1 buprenorphine/naloxone combination tablet can be effectively used to treat patients with opiate dependence in various treatment settings
Release Date
Sep 02, 2015
Description

To determine if the 4:1 buprenorphine/naloxone combination tablet can be effectively used to treat patients with opiate dependence in various treatment settings. Induction will be accomplished with the 4:1 buprenorphine/naloxone combination tablet and flexible dosing data will be obtained.

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Division
HEAL Study
Investigator(s)
Title
A Multicenter Safety Trial of Buprenorphine/Naloxone for the Treatment of Opiate Dependence
Short Description
This 52-week study is designed to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.
Release Date
Dec 04, 2014
Description

This 52-week study is designed to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

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Division
HEAL Study
Title
A Multicenter Efficacy/Safety Trial of Buprenorphine/Naloxone for the Treatment of Opiate Dependence
Short Description
This 52-week study is designed to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.
Release Date
Dec 04, 2014
Description

This 52-week study is designed to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

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Division
HEAL Study
Title
A Multicenter Clinical Trial of Buprenorphine in Treatment of Opiate Dependence
Short Description
The primary purpose of this 16-week maintenance study is to determine the safety and effectiveness of 8 mg per day sublingual buprenorphine as compared to 1 mg per day sublingual buprenorphine in decreasing illicit opiate use as measured by urine testing 3 times a week, retention rates, and opiate craving and global rating scores in patients who meet DSM-III-R criteria for opiate dependence.
Release Date
Sep 02, 2015
Description

The primary purpose of this 16-week maintenance study is to determine the safety and effectiveness of 8 mg per day sublingual buprenorphine as compared to 1 mg per day sublingual buprenorphine in decreasing illicit opiate use as measured by urine testing 3 times a week, retention rates, and opiate craving and global rating scores in patients who meet DSM-III-R criteria for opiate dependence. A secondary purpose of the study is to gather more experience with two other doses of buprenorphine, 4 mg per day and 16 mg per day, regarding safety in the same population. Because the data will be used to support an NDA for buprenorphine in the treatment of opiate dependence, the data will be collected using FDA guidelines for good clinical practices.

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Case Report Form(s)
Deidentification Notes
Nulled Values
Division
HEAL Study
Investigator(s)
Title
Double-Blind, Placebo-Controlled Assessment Of Potential Interactions Between Intravenous Methamphetamine And Osmotic-Release Methylphenidate (Oros-Mph)
Short Description
This is a human inpatient clinical pharmacology study to assess potential interactions between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate (OROS-MPH).
Release Date
Dec 04, 2014
Description

The primary objective of this study is to determine the safety of the OROS-MPH concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures include cardiovascular responses [heart rate (HR), blood pressure (BP), and electrocardiograph (ECG) measurements], oral temperature, adverse events (AEs), and clinical laboratory analyses.

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Youth Self-Report

Submitted by administrator on
Abbreviation
YSR
Description
The Youth Status Report questionnaire has been widely used with adolescents. The YSR is designed for individuals 11-18 who are still in school. Each measure both competencies and internalizing and externalizing problems among individuals in their specified age groups. It is easy to administer, well accepted, and supported by an enormous body of research demonstrating validity and reliability. Problem scales include scores for withdrawal, somatic complaints, anxiety and depression, social problems, thought problems, attention problems, delinquent behavior, aggressive behavior, self-destructive behavior, and total problem behaviors. It takes about 40 minutes. This instrument is copyrighted and a use license has been obtained for this study.
Category
Substance Use
Subcategory
Drugs

Young Adult Self Report

Submitted by administrator on
Abbreviation
YASR
Description
The Young Adult Self Report questionnaire has been widely used with young adults. The YASR is used with young adults aged 18-30; it measures both competencies and internalizing and externalizing problems among individuals in their specified age groups. They are easy to administer, well accepted, and supported by an enormous body of research demonstrating validity and reliability. Problem scales include scores for withdrawal, somatic complaints, anxiety and depression, social problems, thought problems, attention problems, delinquent behavior, aggressive behavior, self-destructive behavior, and total problem behaviors. It takes about 40 minutes. This instrument is copyrighted and a use license has been obtained for this study.