Division
HEAL Study
Title
Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers
Short Description
To assess the safety, tolerance, and pharmacokinetics of multiple escalating dosages of oral GBR 12909 in cocaine experienced volunteers.
Release Date
May 23, 2017
Description

This is a human laboratory study that will assess the clinical pharmacology, safety and tolerance of three escalating oral doses of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride, in cocaine experienced volunteers.

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Study Data
Study Links
Study Documents
Case Report Form(s)
Deidentification Notes
Nulled Values
All Documents

Immediate Memory Task/Delayed Memory Task

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Abbreviation
IMT/DMT
Description

The IMT/DMT (Dougherty, Marsh, & Mathias, 2002) is a continuous performance test that was designed to assess impulsive behavior. The Immediate Memory Task involves comparison of consecutively presented numbers and responding in those instances when the current number matches the number immediately before it (called a correct detection). The Delayed Memory Task similarly involves responding to matching numbers, but the numbers to be compared are separated by a filler sequence (e.g. 12345).

Category
Impulsivity and General Trait & Behavior Scales

Change in Sexual Function Questionnaire

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Abbreviation
CSFQ
Description

The CSFQ is a 36-item questionnaire designed to measure sexual functioning. It is a self-administered assessment that asks the subject to rate changes in his or her sexual function. The CSFQ total score ratings serve as indicators of comorbidity- or medication-related sexual dysfunction.

Category
Physical/General Health

Systematic Assessment for Treatment Emergent Effects

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Abbreviation
SAFTEE
Description

The SAFTEE is a technique for the systematic assessment of side effects in clinical trials developed by National Institute of Mental Health (Levine & Schooler, 1986). It is a questionnaire that rates the current severity of a wide range of somatic, behavioral and affective symptoms in general and specific inquiry formats. It is designed to report adverse health events, regardless of whether or not they are suspected to be drug related, in order to reduce the under-reporting of unanticipated events compared with "known or expected" events.

Category
Physical/General Health
Division
HEAL Study
Title
Cocaine-Metyrapone Interaction Study
Short Description
The primary goal of this study is to evaluate the safety of conducting an outpatient MRP study in which participants would be given two 750 mg doses of MRP per week.
Release Date
Aug 01, 2016
Description

The primary objectives of this study are:
1. To demonstrate that a 750 mg dose of MRP is safe when used concomitantly with cocaine.
2. To demonstrate that a 750 mg dose of MRP is safe to use two days in a row.
3. To determine whether MRP can block the cocaine craving and physiological symptoms induced by cocaine cues (i.e., CR).
4. To determine whether MRP can block the cocaine craving and physiological symptoms induced by a personal stress situation (i.e., SI).
5. To determine whether MRP can modify the subjective and physiologic effects of cocaine.

Accessibility Notice

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

Study Data
Study Links
Study Documents
Case Report Form(s)
Deidentification Notes
Nulled Values
All Documents