Division
HEAL Study
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Cabergoline For The Treatment Of Cocaine Dependence
Short Description
To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that cabergoline treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Release Date
Dec 21, 2017
Description

The primary objective of this study is to assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence (DSM-IV criteria). The hypothesis is that cabergoline will increase the weekly mean proportion of cocaine non-use days over the treatment period as compared to placebo as determined by self-report of cocaine use confirmed with urine assays for BE.

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
Division
HEAL Study
Investigator(s)
Title
A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal
Short Description
The value of this pivotal Phase 3 efficacy trial is to investigate if a nonopiate such as lofexidine, an alpha-2-adrenergic agonist, is an effective medication for the alleviation of opiate detoxification symptoms in opiate dependent individuals.
Release Date
Dec 21, 2017
Description

The primary outcome measure is the Modified Himmelsbach Opiate Withdrawal Scale (MHOWS), an objective assessment of the severity of opiate withdrawal symptoms, obtained on the second opiate detoxification day. It is hypothesized that the MHOWS scores will be significantly lower in the lofexidine as compared with the placebo group. Subjects will be medically discharged on the morning of the 11th day.

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
Dictionary
Case Report Form(s)
Deidentification Notes

Trail Making Test

Submitted by administrator on
Abbreviation
TMT
Description

A test assessing organized visual search, planning, attention, set shifting, cognitive flexibility, and divided attention (Rabin, Barr, & Butler, 2005), all capacities thought to be executive in nature. Originally developed by Partington (Brown & Partington, 1942), it was first published as part of the Army Individual Test Battery (1984). The test is currently available in public domain (see Lezak, Howieson, Loring, Hannay, & Fischer, 2004; Strauss, Sherman, & Spreen, 2006). The standard trail-making test (TMT) contains two parts: Trails A and Trails B, which usually takes no more than 5–10 min to complete.

Category
Impulsivity and General Trait & Behavior Scales

Positive Symptom Rating Scale

Submitted by administrator on
Abbreviation
PSRS
Description

PSRS is a psychiatric assessment that has been modified from a longer form of the BPRS (Brief Psychiatric Rating Scale) to assess temporal paranoia or agitation. The PSRS consists of a 4-item Positive Symptom Rating Scale (1. Suspiciousness; 2. Unusual Thought Content; 3. Hallucinations; 4. Conceptual Disorganization). It is an interviewer-administered assessment. The responses for the Positive Symptom Rating Scale are rated on a 7-point scale (1. Not Present; through 7. Extremely Severe).

Category
Mental Health
Subcategory
Anxiety

Subtraction Stress Task

Submitted by administrator on
Abbreviation
SST
Description

The SST is a computerized task that consists of five 1-minute epochs of serial subtraction with the minuend and subtrahend changed at the beginning of each minute based on each individual subject’s ability.

Category
Impulsivity and General Trait & Behavior Scales