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.

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Division
HEAL Study
Investigator(s)
Title
Assessment Of Potential Interactions Between Intravenous Methamphetamine And Oral Selegiline
Short Description
This is a human laboratory clinical pharmacology study to assess potential interactions between intravenous methamphetamine challenge and treatment with oral selegiline.
Release Date
Aug 01, 2016
Description

The primary objective of this study is to determine the safety of the selegiline concurrent with dmethamphetamine challenges of 15 mg and 30 mg i.v. The primary outcome measures are cardiovascular responses (HR, BP) to the i.v. methamphetamine challenges.

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Division
HEAL Study
Investigator(s)
Title
Assessment Of Potential Interactions Between Intravenous Cocaine And Tolcapone
Short Description
This is a human laboratory clinical pharmacology study to assess potential interactions between intravenous cocaine infusion and treatment with tolcapone.
Release Date
Aug 01, 2016
Description

The primary objective of this study is to determine the safety of tolcapone treatment, compared to placebo treatment, concurrent with i.v. cocaine infusions of 20 and 40 mg, with the focus being on cardiovascular responses (HR, BP) to the i.v. cocaine infusions.

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Study Links
Division
HEAL Study
Title
Safety Evaluation Of Cocaine Treatment Medication, Modafinil: Interactions With Intravenous Cocaine
Short Description
A study to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
Release Date
Aug 01, 2016
Description

The primary objectives of this study are to determine:
1. The safety/tolerability of modafinil as a cocaine treatment medication in cocaine dependent subjects.
2. If administration of intravenous cocaine to subjects (who have demonstrated ability to tolerate the intravenous (i.v.) cocaine administration) maintained on modafinil results in any adverse effects.
3. To determine if there is a pharmacokinetic interaction between cocaine and modafinil.
The secondary objective is to determine: The ability of modafinil to modify the cocaine-related “high” as well as dysphoric reactions to cocaine withdrawal.

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Profile of Mood States

Abbreviation
POMS
Description

Since its release in 1971, the POMS assessment has proven itself to be an excellent measure of affective mood state fluctuation in a wide variety of populations including psychiatric outpatients, medical patients, and in sports psychology. It is suitable for individuals aged 18 and older, and can be completed individually or in groups. The POMS Standard uses a 65-item, 5-point adjective rating scale, while the POMS Brief is based on 30 questions. Both versions of POMS measure six identifiable mood or affective states: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment.

Category
Mental Health
Subcategory
General/Multiple Disorders

Brief Psychiatric Rating Scale

Abbreviation
BPRS
Description

The BPRS is a clinician-rated tool designed to assess change in severity of psychopathology. It has been in widespread use for more than 30 years and remains popular for research studies that assess patient change in response to treatment interventions. It is an 18-item scale measuring positive symptoms, general psychopathology and affective symptoms. Each symptom construct is rated on a 7-point scale of severity ranging from 'not present' to 'extremely severe.' It takes approximately 20-30 minutes to administer the BPRS.

Category
Mental Health
Subcategory
General/Multiple Disorders

Structured Clinical Interview for DSM Disorders

Abbreviation
SCID
Description

The SCID-I is a semi-structured interview used to assess the major DSM-IV Axis I diagnoses. The SCID-II is a semi-structured interview for making Axis II (Personality Disorder) diagnoses. Each instrument comes in two versions -- the clinician version, a streamlined version published in two parts, and the research version, which is much easier to modify for a particular study and is more complete. The instrument is designed to be administered by a clinician or trained mental health professional and takes between 1 to 2 hours to complete. Because of its modular format, the SCID can be shortened by focusing only on the diagnoses of interest.

Category
Mental Health
Subcategory
General/Multiple Disorders

ECG Monitoring

Abbreviation
ECGMON
Description

Repeating assessment of electrical and muscular heart functions

Category
Clinical Measures