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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Study Data
Study Links
Study Documents
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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Study Data
Study Links
Study Documents
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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Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
Study Links
Study Documents
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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Study Data
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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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Study Data
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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.

WRAT Reading section

Submitted by administrator on
Abbreviation
WRAT
Description
The WRAT-3 assesses academic achievement and functioning (i.e., assigns grade level for reading, arithmetic and spelling; Wilkinson, 1993). The WRAT has excellent reliability and validity and is frequently used both for clinical/educational as well as research purposes to measure academic achievement.
Category
Impulsivity and General Trait & Behavior Scales

World Health Organization Quality of Life-BREF

Submitted by administrator on
Abbreviation
WHOQOL
Description
The original 100-item WHOQOL allows for a detailed assessment of individual facets relating to quality of life, but may be too lengthy for some uses, such as large epidemiological studies where quality of life is only one amongst many variables of interest. The WHOQOL-BREF comprises 26 items measuring the following broad domains: physical health, psychological health, social relationships, and environment.
Category
Health Cognitions & QOL

Working Alliance Inventory- Short Version

Submitted by administrator on
Abbreviation
WAI-C
Description

A rating scale designed to measure the working alliance between counselors and their clients during therapy sessions. Both counselors and clients complete different versions of the inventory. The scales are designed to yield three measures: Goal (whether the client and therapist agree on goals of treatment); Task (whether they agree on how to achieve those goals); and Bond (whether they will be able to or have already established a personal bond with each other).

Category
Interpersonal Relationships/Culture