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 Links
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 Links

Youth Self-Report

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

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

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

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

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

Withdrawal Scale for Tobacco

Abbreviation
WST
Description
The WST is a modified version of the Minnesota Withdrawal Scale [Hughes et al, 1991; Hatsukami et al, 1997; Hughes and Hatsukami, 1986]. The WST is a self-report questionnaire which asks participants to rate 9 items of withdrawal on a scale from 0=None to 4=Severe. A total score is then computed from the responses to these 9 items. In addition, the 9 items are also examined separately.
Category
Substance Use
Subcategory
Tobacco

Wisconsin Card Sorting Task

Abbreviation
WCST
Description
The Wisconsin Card Sorting Test (WCST; Grant and Berg, 1948) is a neuropsychological test of the ability to display flexibility in the face of changing schedules of reinforcement. It requires subjects to find the correct classification principle, by trial and error and examiner feedback, of geometric figures that vary by color, form, or number.
Category
Impulsivity and General Trait & Behavior Scales

Wender Utah Rating Scale

Abbreviation
WURS
Description
The Wender Utah Rating Scale (WURS; Ward, Wender, Reimherr, 1993) is a 61-item assessment for Attention Deficit Hyperactivity Disorder, in which the adult patient recalls his or her childhood behavior. Items fall into three factors: dysthymia, oppositional/defiant behavior, and school (work) problems.
Category
Mental Health
Subcategory
ADHD