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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Addiction

Intervention: TV-1380 150 mg (Drug); TV-1380 300 mg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

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.

Clinical Details

Official title: A 12-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Once-Weekly Intra-Muscular Injections of TV-1380 (150 mg/Week or 300 mg/Week) as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Urine test for cocaine

Secondary outcome:

Percent of urine samples that are considered negative for cocaine metabolites.

Summary of participants with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Teva Investigational Site 31064, Alicante, Spain

Teva Investigational Site 31063, Barcelona, Spain

Teva Investigational Site 31065, Barcelona, Spain

Teva Investigational Site 31069, Barcelona, Spain

Teva Investigational Site 31068, Madrid, Spain

Teva Investigational Site 10663, Los Angeles, California, United States

Teva Investigational Site 10665, Oceanside, California, United States

Teva Investigational Site 10659, San Francisco, California, United States

Teva Investigational Site 10746, Torrance, California, United States

Teva Investigational Site 10664, North Miami, Florida, United States

Teva Investigational Site 10661, Boston, Massachusetts, United States

Teva Investigational Site 10668, New Bedford, Massachusetts, United States

Teva Investigational Site 10747, St Louis, Missouri, United States

Teva Investigational Site 10745, Las Vagas, Nevada, United States

Teva Investigational Site 10667, Marlton, New Jersey, United States

Teva Investigational Site 10662, Columbus, Ohio, United States

Teva Investigational Site 10660, Pittsburgh, Pennsylvania, United States

Teva Investigational Site 10658, Charleston, South Carolina, United States

Teva Investigational Site 10666, Salt Lake City, Utah, United States

Additional Information

Starting date: June 2013
Last updated: February 12, 2015

Page last updated: August 23, 2015

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