Overview

A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Indivior Inc.
Treatments:
Cocaine
Criteria
Inclusion Criteria:

- Male and female volunteers aged 21-50 years, inclusive

- Body mass index (BMI)18-32 kg/m^2 and weight of at least 50 kg

- Not currently seeking treatment for substance abuse or substance dependence

- Subject is healthy, in the opinion of the Principal Investigator other than cocaine
abuse; as determined by the absence of clinically significant medical/psychiatric
history or findings, particularly cardiovascular or central nervous system (CNS)
disease, physical examination, normal renal function, ECG findings, vital signs, and
laboratory results at screening

- Males agree to refrain from sperm donations for the entire duration of the study, and
for at least 90 days after the last dose of study drug

- Has experience using cocaine by the smoked or IV route at least 6 times in past 12
months and a positive urine drug screen for cocaine prior to study intake (Day -2).
Has experience using cocaine by the smoked or IV route in the past 3 months and a
positive urine drug screen for cocaine during screening prior to study check-in at the
clinic

- Be able to verbalize understanding of the consent form, able to provide written
informed consent, and verbalize willingness to complete study procedures, prior to the
initiation of any protocol-specific procedures

- Meet DSM-IV-TR criteria for current cocaine abuse

- Be able to comply with protocol requirements, rules, and regulations of the study
site, and be likely to complete all the study procedures in the opinion of the
Principal Investigator

Exclusion Criteria:

- Current or past history of seizure disorder, including alcohol- and/or
stimulant-related seizure, febrile seizure, or significant family history of
idiopathic seizure disorder. Have any previous clinically significant reaction to
cocaine, including loss of consciousness or seizure

- Current alcohol dependence or current drug dependence according to DSM-IV-TR criteria
(excluding nicotine and caffeine)

- Clinically significant history of cardiac disease, including cardiovascular and
conduction abnormalities or ECG evidence of cardiac abnormalities

- QTcF greater than or equal to 450 for male subjects and 470 for female subjects as
measured through a 12-lead ECG

- History of liver disease or current elevation of aspartate aminotransferase (AST) or
alanine aminotransferase (ALT) exceeding 3x the upper limit of normal

- Be on probation or parole, and/or have current or pending legal charges with the
potential for incarceration that could interfere with the study scheduling

- Women with a positive pregnancy test at screening; or women who are pregnant or
lactating or who are seeking to become pregnant

- Women of childbearing potential (who are sexually active with a male) who fail to use
medically acceptable contraception methods (e.g., an oral or injectable contraceptive,
an approved hormonal implant or topical patch, an intrauterine device, a double
barrier method, or barrier plus spermicide). A woman of childbearing potential is
defined as any female who is less than 2 years post-menopausal or has not undergone a
hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral
ovariectomy (oophorectomy). Females that are post-menopausal will be confirmed as such
by the follicle stimulating hormone (FSH) test at initial screening

- Males who do not agree to use barrier contraception and spermicide when engaging in
sexual activity with a female of child-bearing potential while on study medication,
and for at least 28 days after the last dose of study medication

- History of clinically significant severe allergic or anaphylactic reactions