NCT01887366

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cocaine Addiction

Interventions

Type	Name	Description
DRUG	TV-1380 150 mg	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).
DRUG	TV-1380 300 mg	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.
DRUG	Placebo	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-06-26
• Last updated: 2015-11-05

Locations

19 sites across 2 countries: United States, Spain