Clinical trial NCT01887366: Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Addiction
Keywords: Cocaine addiction
TV-1380
Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Urine test for cocaine
timeFrame: Treatment Phase weeks 10 - 12
Secondary outcomes:
measure: Percent of urine samples that are considered negative for cocaine metabolites.
timeFrame: Treatment Phase Weeks 5 -12
measure: Summary of participants with adverse events
timeFrame: From signing of the informed consent form to the end of the follow-up period (Week 16)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Teva Investigational Site 10663
state: California
city: Oceanside
country: United States
facility: Teva Investigational Site 10665
state: California
city: San Francisco
country: United States
facility: Teva Investigational Site 10659
state: California
city: Torrance
country: United States
facility: Teva Investigational Site 10746
state: California
city: North Miami
country: United States
facility: Teva Investigational Site 10664
state: Florida
city: Boston
country: United States
facility: Teva Investigational Site 10661
state: Massachusetts
city: New Bedford
country: United States
facility: Teva Investigational Site 10668
state: Massachusetts
city: St Louis
country: United States
facility: Teva Investigational Site 10747
state: Missouri
city: Las Vagas
country: United States
facility: Teva Investigational Site 10745
state: Nevada
city: Marlton
country: United States
facility: Teva Investigational Site 10667
state: New Jersey
city: Columbus
country: United States
facility: Teva Investigational Site 10662
state: Ohio
city: Pittsburgh
country: United States
facility: Teva Investigational Site 10660
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Investigational Site 10658
state: South Carolina
city: Salt Lake City
country: United States
facility: Teva Investigational Site 10666
state: Utah
city: Alicante
country: Spain
facility: Teva Investigational Site 31064
city: Barcelona
country: Spain
facility: Teva Investigational Site 31063
city: Barcelona
country: Spain
facility: Teva Investigational Site 31065
city: Barcelona
country: Spain
facility: Teva Investigational Site 31069
city: Madrid
country: Spain
facility: Teva Investigational Site 31068
Study officials:
References: