Division
HEAL Study
Investigator(s)
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Tiagabine For The Treatment Of Cocaine Dependence
Short Description
The study objective is to assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine 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
Jan 15, 2019
Description

This is a double-blind, placebo-controlled, parallel-group design study in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to one of two treatment groups, tiagabine or matched placebo. All patients will receive manualguided cognitive behavioral therapy (CBT). Medication dosing will occur over 15 weeks with the first three weeks being dose escalation and the last three weeks being dose taper. Follow-up will consist of assessments once each week during weeks 13, 14, 15, and 19. Randomization strata include study site, gender and frequency of cocaine use in the 30 days prior to screening.

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Study Data
Study Links
Study Documents

Service Utilization Adherence Measurement

Abbreviation
SUAM
Description

A self-reported use of health care services, consisting of 18 items and subscales according to the type of health care visit: Emergency room, Inpatient, Nursing home, Day Hospital, Clinic, Doctor’s Office, Mental Health Care, Residential treatment for substance use, Outpatient Treatment for substance use, Self help support group, Dental Care, Formal home care, or Case Management (HIV/AIDS Treatment Adherence, Health Outcomes and Cost Study Group, 2004).

Category
Physical/General Health

Medical Mistrust Scale

Abbreviation
MMS
Description

An 12-item assessment of the tendency to distrust mainstream health care professionals and health care systems, with responses on a Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree) (Thompson, Vladimarsdottir, Winkel, Jandorf, & Redd, 2004).

Category
Mental Health
Health Cognitions & QOL

Interpersonal Violence Scale

Abbreviation
IPV
Description

A 5-item measure adapted from STaT (Slapped, Threatened, and Throw), an instrument that was developed to succinctly screen for lifetime IPV in a clinical setting and was previously validated in urban emergency departments (Paranjape, Rask, & Liebschutz, 2006; Paranjape, & Liebschutz, 2003).

Category
Interpersonal Relationships/Culture

International HIV Dementia Scale

Abbreviation
IHDS
Description

A cross-cultural screening test to detect HIV dementia within the international community,  consisting of three subtests: timed fingertapping, timed alternating hand sequence test, and recall of four items at 2 min (Sacktor et al., 2005).

Category
Mental Health

Household Food Insecurity Access Scale

Abbreviation
HFIAS
Description

An assessment using 9 specific questions about worry and availability of and accessibility to
foods for the household during the previous 30 days, that have been used in several countries and appear to distinguish food-insecure from food-secure households across different cultural contexts (Coates, Swindale, & Bilinsky, 2007).

Category
Health Cognitions & QOL

HIV Treatment Adherence Self-Efficacy Scale

Abbreviation
HIV-ASES
Description

A 12-item scale (Johnson et al., 2007) of patient confidence to carry out important treatment-related behaviors related to adhering to treatment plans, including medication regimen adherence and following plans for nutrition, exercise, etc, in the face of barriers. Reponses range from 1 (cannot do it at all) to 10 (certain can do it).

Category
Sexual Behavior/HIV