A 12-week study in cocaine dependent subjects to evaluate safety and efficacy of a once-weekly intra-muscular injection of TV1380 (150mg/week or 300mg/per week) as a treatment to facilitate cocaine abstinence compared to placebo.

Conditions: Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
MedDRA version: 16.0Level: LLTClassification code 10009815Term: Cocaine addictionSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

Registration Number: EUCTR2013-000208-41-ES

Lead Sponsor: Teva Pharmaceutical Industries Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

Inclusion Criteria

a. Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
b. Male or female aged 18-60 years (inclusive).
c. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for cocaine dependence as determined by the Structured Clinical Interview (SCID) in screening.
d. Seek treatment for cocaine dependence.
e. Provide at least four urine samples and have at least one cocaine-positive urine sample during the two-week screening period as measured by an on-site, qualitative benzoylecgonine (BE) assay.
f. Have a home address and can give contact locator information.
g. Are, in the opinion of the investigator, likely to complete the 12-week treatment phase of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Meet DSM-IV-TR criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana OR have physiological dependence on alcohol requiring detoxification.
b. Have all the available urine tests positive for opiates during the 2 weeks screening period (episodic urine tests positive for opiates are allowed).
c. Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening.
d. Have one or more severe psychiatric disorders as determined by the Mini International Neuropsychiatric Interview (MINI) such as psychosis, schizophrenia, bipolar disease, major depression, or eating disorders in screening.
e. Have one or more major neurologic disorders such as dementia or organic brain disease.
f. Have other serious medical illnesses or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site MD.
g. Had previous suicidal attempt or current suicidal risk as determined by the site MD
h. Have liver function tests (ALT, AST) greater than x3 times upper limit of normal (ULN) or any other clinically significant abnormal laboratory value during the screening period as determined by the site MD.
i. Have known allergy or hypersensitivity to natural or recombinant butyrylcholinesterase (BChE), human serum albumin (HSA) or any other component of the formulation.
j. Current court mandated cocaine use treatment.
k. Have been treated for cocaine addiction within the 30 days preceding screening.
l. Are unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
m. Have taken any investigational drugs within 60 days preceding screening.
n. Have participated in an experimental trial assessing a cocaine vaccine anytime before study screening.
o. Are currently exposed to or have been exposed to pesticides or any other organophosphates (e.g., agricultural workers) within 60 days preceding screening.
p. Women of child-bearing potential who do not practice an acceptable method of birth control.
q. Pregnant or nursing women.