Division
HEAL Study
Investigator(s)
Title
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Short Description
Assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.
Release Date
Jan 12, 2018
Description

The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments. The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid).

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Division
HEAL Study
Investigator(s)
Title
Phase I, Double-Blind, Placebo-Controlled Assessment Of Potential Interactions Between Intravenous Cocaine And Ethanol And Oral Disulfiram
Short Description
The primary outcome measures to address the safety of disulfiram treatment are adverse events, changes in cardiac (ECG) and cardiovascular responses (HR, BP) and observations of significant negative psychiatric effects (mPSRS, as well as POMS and self-rated DER) from disulfiram, ethanol and cocaine.
Release Date
Dec 21, 2017
Description

The primary study objective is to assess the safety of disulfiram as a putative cocaine treatment agent by increasing our understanding of how disulfiram alters the cocaine response and how the addition of small doses of ethanol may alter this cocaine response. Satisfaction of this objective is required before the FDA will consider approval of further clinical trials with disulfiram treatment for cocaine dependence.

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Division
HEAL Study
Investigator(s)
Title
Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil
Short Description
Study to assess the potential interactions between intravenous methamphetamine and oral Modafinil
Release Date
Dec 21, 2017
Description

The primary aims of this study are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).

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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.

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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.

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Trail Making Test

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

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

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