Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects

Phase 2

Completed

• Conditions: Cocaine Addiction
• Interventions: Drug: TV-1380 150 mg; Drug: TV-1380 300 mg; Drug: Placebo

• Registration Number: NCT01887366
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

The primary objective of this study is to assess the efficacy and safety of TV-1380 \[Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)\] in facilitating abstinence in cocaine-dependent subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-26
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-10
• Disposition First Submitted: 2015-10-12
• Disposition First Submitted QC: 2015-10-12
• Last Update Submitted: 2015-10-12
• Disposition First Posted: 2015-11-05
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
• Male or female aged 18-60 years (inclusive).
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
• Other criteria apply; please contact the site for more information.

Exclusion Criteria

• Meet criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana OR have physiological dependence on alcohol requiring detoxification.
• Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening.
• 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.
• Have one or more major neurologic disorders such as dementia or organic brain disease.
• Have other serious medical illnesses (including but not limited to uncontrolled hypertension, significant heart disease, respiratory disease including asthma, hepatic disease, renal disease, AIDS) or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site MD.
• Other criteria apply; please contact the site for more information.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TV-1380 150 mg	TV-1380 150 mg	-
TV-1380 300 mg	TV-1380 300 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Urine test for cocaine	Treatment Phase weeks 10 - 12

Secondary Outcome Measures

Name	Time	Method
Percent of urine samples that are considered negative for cocaine metabolites.	Treatment Phase Weeks 5 -12
Summary of participants with adverse events	From signing of the informed consent form to the end of the follow-up period (Week 16)

Trial Locations

Locations (19)

Teva Investigational Site 10665; 🇺🇸 Oceanside, California, United States

Teva Investigational Site 10745; 🇺🇸 Las Vagas, Nevada, United States

Teva Investigational Site 10667; 🇺🇸 Marlton, New Jersey, United States

Teva Investigational Site 10658; 🇺🇸 Charleston, South Carolina, United States

Teva Investigational Site 31064; 🇪🇸 Alicante, Spain

Teva Investigational Site 10664; 🇺🇸 North Miami, Florida, United States

Teva Investigational Site 31063; 🇪🇸 Barcelona, Spain

Teva Investigational Site 31065; 🇪🇸 Barcelona, Spain

Teva Investigational Site 31068; 🇪🇸 Madrid, Spain

Teva Investigational Site 10666; 🇺🇸 Salt Lake City, Utah, United States

Teva Investigational Site 10659; 🇺🇸 San Francisco, California, United States

Teva Investigational Site 10668; 🇺🇸 New Bedford, Massachusetts, United States

Teva Investigational Site 10747; 🇺🇸 St Louis, Missouri, United States

Teva Investigational Site 10660; 🇺🇸 Pittsburgh, Pennsylvania, United States

Teva Investigational Site 10663; 🇺🇸 Los Angeles, California, United States

Teva Investigational Site 10746; 🇺🇸 Torrance, California, United States

Teva Investigational Site 10661; 🇺🇸 Boston, Massachusetts, United States

Teva Investigational Site 10662; 🇺🇸 Columbus, Ohio, United States

Teva Investigational Site 31069; 🇪🇸 Barcelona, Spain