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

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