CD4 T-cell Count

Abbreviation
CD4-Test
Description

Blood specimens sent to lab for CD4 testing using plasma samples; or on-site via PIMA POC CD4 analyzer (Alere Healthcare, USA) using venous whole blood samples.

Category
Clinical Measures
Division
HEAL Study
Title
Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers.
Short Description
To assess the safety, tolerance, and pharmacokinetics of multiple dosages of 75mg oral GBR 12909 in cocaine experienced volunteers. Effects on WBC and ANC will be the primary hematology outcome measure.
Release Date
May 23, 2017
Description

This is a human laboratory study that will assess the clinical pharmacology, safety and tolerance of 75mg oral doses of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride, in cocaine experienced volunteers. Particular interest is being given to the hematological safety data.

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Study Links
Division
HEAL Study
Title
Study of Interactions Between GBR 12909 and Cocaine
Short Description
This is a human laboratory clinical pharmacology study that will assess potential interactions between intravenous (i.v.) cocaine and three escalating oral doses (50, 70 and 100 mg) of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride.
Release Date
May 23, 2017
Description

The primary objective of this study is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with i.v. cocaine infusions of 20 and 40 mg by measuring adverse events and cardiovascular responses [heart rate (HR), blood pressure (BP), and electrocardiogram (ECG)]. Note: A significant interaction is defined as: more than 50% of the subjects treated with GBR 12909 experience a pharmacodynamic interaction when challenged with cocaine, which brings the stopping criteria (section 12.4.5) into effect.

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Study Links
Division
HEAL Study
Investigator(s)
Title
A Phase 1 Parallel-Group, Double-Blind, Placebo-Controlled Cardiovascular and Behavioral Study Assessing Interactions Between Single Doses of Oral Reserpine and Intravenous Methamphetamine
Short Description
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.
Release Date
May 23, 2017
Description

This 7-day double-blind, parallel-group, placebo-controlled inpatient study will compare the effects of 15 mg of intravenous methamphetamine given 60 hours before and 12 hours after a single oral dose of reserpine (0.5 or 1.0 mg) or placebo.

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Study Links
Division
HEAL Study
Title
Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681
Short Description
This is a human laboratory clinical pharmacology study to assess potential interactions between intravenous (i.v.) cocaine and RPR 102681 administered in 3 escalating doses.
Release Date
May 23, 2017
Description

The primary objective of this study is to determine if there are significant interactions between RPR 102681 treatment concurrent with i.v. cocaine infusions of 0 and 40 mg by measuring adverse events and cardiovascular responses [heart rate (HR), blood pressure (BP), and electrocardiogram (ECG)].

Accessibility Notice

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

Study Links
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.

Accessibility Notice

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

Study Links

Immediate Memory Task/Delayed Memory Task

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

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

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