Cocaine Addiction Clinical Trial
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
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.
Status | Completed |
Enrollment | 208 |
Est. completion date | October 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | 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 | |
United States | Teva Investigational Site 10661 | Boston | Massachusetts |
United States | Teva Investigational Site 10658 | Charleston | South Carolina |
United States | Teva Investigational Site 10662 | Columbus | Ohio |
United States | Teva Investigational Site 10745 | Las Vagas | Nevada |
United States | Teva Investigational Site 10663 | Los Angeles | California |
United States | Teva Investigational Site 10667 | Marlton | New Jersey |
United States | Teva Investigational Site 10668 | New Bedford | Massachusetts |
United States | Teva Investigational Site 10664 | North Miami | Florida |
United States | Teva Investigational Site 10665 | Oceanside | California |
United States | Teva Investigational Site 10660 | Pittsburgh | Pennsylvania |
United States | Teva Investigational Site 10666 | Salt Lake City | Utah |
United States | Teva Investigational Site 10659 | San Francisco | California |
United States | Teva Investigational Site 10747 | St Louis | Missouri |
United States | Teva Investigational Site 10746 | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Teva Pharmaceutical Industries |
United States, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine test for cocaine | Treatment Phase weeks 10 - 12 | No | |
Secondary | Percent of urine samples that are considered negative for cocaine metabolites. | Treatment Phase Weeks 5 -12 | No | |
Secondary | Summary of participants with adverse events | From signing of the informed consent form to the end of the follow-up period (Week 16) | Yes |
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