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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Addiction

In brief

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.

Key facts

Study ID

NCT01887366

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

208

Starts

2013-06-01

Expected to finish

2014-10-01

Last updated by the study team

2015-11-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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