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Division
DTMC
HEAL Study
No
Investigator(s)
Kathryn Cunningham, Ph.D.
John Grabowski, Ph.D.
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.

Keywords
cocaine
gbr12909
interaction
phase 1b
stimulant
Assessments
Addiction Research Center Inventory
Barratt Impulsiveness Scale
Beck Depression Inventory
Blood Cocaine Level
Blood Study Agent Level
Brief Psychiatric Rating Scale
Brief Substance Craving Scale
Brief Symptom Inventory
ECG Monitoring
HIV Risk-Taking Behaviour Scale
Immediate Memory Task/Delayed Memory Task
Profile of Mood States
Visual Analog Scales
Vital Signs Monitoring
Accessibility Notice

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

Study Data
CPU-0004 Data
Study Links
ClinicalTrials.gov Link
CPU-0004 in NIH clinical trials registry
Study Documents
Protocol
CPU0004-Protocol.pdf
Dictionary
CPU0004-Dictionary.xlsx
Case Report Form(s)
CPU0004-CRF.pdf
Deidentification Notes
CPU0004-DeidentificationNotes.pdf
Nulled Values
CPU0004-NulledValues.csv
All Documents
CPU0004-AllDocuments.zip
Division
DTMC
HEAL Study
No
Investigator(s)
Reese Jones, M.D.
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.

Keywords
interaction
methamphetamine
phase 1a
reserpine
stimulant
Assessments
Addiction Research Center Inventory
Brief Substance Craving Scale
Change in Sexual Function Questionnaire
ECG Monitoring
McLean Hospital Event Overt Aggression Checklist
Systematic Assessment for Treatment Emergent Effects
Vital Signs Monitoring
Accessibility Notice

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

Study Data
CPU-0006 Data
Study Links
ClinicalTrials.gov Link
CPU-0006 in NIH clinical trials registry
Study Documents
Protocol
CPU0006-Protocol.pdf
Dictionary
CPU0006-Dictionary.xlsx
Case Report Form(s)
CPU0006-CRF.pdf
Deidentification Notes
CPU0006-DeidentificationNotes.pdf
Nulled Values
CPU0006-NulledValues.csv
All Documents
CPU0006-AllDocuments.zip
Division
DTMC
HEAL Study
No
Investigator(s)
Louis Cantilena, Jr., M.D, Ph.D.
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)].

Keywords
cocaine
interaction
phase 1b
rpr102681
stimulant
Assessments
Addiction Research Center Inventory
Beck Depression Inventory
Blood Cocaine Level
Blood Study Agent Level
Brief Psychiatric Rating Scale
Brief Substance Craving Scale
Brief Symptom Inventory
ECG Monitoring
Profile of Mood States
Visual Analog Scales
Vital Signs Monitoring
Accessibility Notice

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

Study Data
CPU-0003 Data
Study Links
ClinicalTrials.gov Link
CPU-0003 in NIH clinical trials registry
Study Documents
Protocol
CPU0003-Protocol.pdf
Dictionary
CPU0003-Dictionary.xlsx
Case Report Form(s)
CPU0003-CRF.pdf
Deidentification Notes
CPU0003-DeidentificationNotes.pdf
Nulled Values
CPU0003-NulledValues.csv
All Documents
CPU0003-AllDocuments.zip
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