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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents).
Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380.
Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo.
Teva Investigational Site 10663
Los Angeles, California, United States
Teva Investigational Site 10665
Oceanside, California, United States
Urine test for cocaine
Time frame: Treatment Phase weeks 10 - 12
Percent of urine samples that are considered negative for cocaine metabolites.
Time frame: Treatment Phase Weeks 5 -12
Summary of participants with adverse events
Time frame: From signing of the informed consent form to the end of the follow-up period (Week 16)
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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
...and 9 more locations