Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects MedDRA version: 16.0 Level: LLT Classification code 10009815 Term: Cocaine addiction System Organ Class: 100000004873
Conditions
Interventions
Product Name: AlbuBChE
Product Code: TV-1380
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: TV-1380
Other descriptive name: AlbuBChE,
Sponsors
Teva Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy and safety of TV-1380 in facilitating abstinence in cocaine-dependent subjects.;Secondary Objective: The secondary objective of the study is to assess the efficacy of TV-1380 in reducing measures of cocaine use compared to placebo treatment.;Primary end point(s): The primary efficacy endpoint for this study is defined as abstinence from cocaine during the last three weeks of the treatment phase (weeks 10-12), based on daily self-report of no use confirmed by urine samples considered negative for cocaine metabolites.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint for this study is defined as abstinence from cocaine during the last 3 weeks of the treatment phase (weeks 10-12), based on daily self-report of no-use confirmed by urine samples considered negative for cocaine metabolites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective of the study is to assess the efficacy of TV-1380 in reducing measures of cocaine use compared to placebo treatment.;Timepoint(s) of evaluation of this end point: The secondary efficacy endpoint for this study is defined as percent of urine samples that are considered negative for cocaine metabolites out of all planned urine samples during the last 8 weeks of the treatment phase (weeks 5-12, 24 samples). Missing or not analyzable urine samples will be considered as not negative for cocaine metabolites. | — |
Countries
Spain, United States
Contacts
Public ContactClinical Trial Information Desk
Teva Pharma GmbH
Outcome results
None listed