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.

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Division
HEAL Study
Investigator(s)
Title
Double-Blind, Placebo-Controlled Trial Of Ondansetron For The Treatment Of Cocaine Dependence
Short Description
This will be a preliminary assessment of the efficacy and safety of three wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce cocaine use in subjects with cocaine dependence and to determine the optimal dose of ondansetron.
Release Date
Aug 01, 2016
Description

The primary objective of this study is to conduct a preliminary assessment of the possible efficacy of ondansetron to reduce cocaine use in outpatients with cocaine dependence.  Hypotheses are that ondansetron will increase the weekly mean proportion of cocaine non-use days assessed by self report of use and confirmed by urine assays for BE, that the weekly proportion of BE positive urines will be decreased, and that the total number of cocaine-free urines will be increased in groups treated with ondansetron when compared to placebo controls.  The results of this study will be used to design subsequent larger studies to confirm the efficacy of ondansetron. This study is also intended to gather preliminary information on biological or psychosocial characteristics of patients who may show better ondansetron treatment responsiveness. In particular, biological measures reflecting individual differences in serotonergic function are included.

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