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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cocaine Addiction

Intervention / Treatment
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* Drug: TV-1380 150 mg
* Drug: TV-1380 300 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TV-1380 150 mg<br> | Drug: TV-1380 150 mg<br>* 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).<br>* Other names: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE);|
| Experimental: TV-1380 300 mg<br> | Drug: TV-1380 300 mg<br>* 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.<br>* Other names: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine test for cocaine |  | Treatment Phase weeks 10 - 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of urine samples that are considered negative for cocaine metabolites. |  | Treatment Phase Weeks 5 -12 | 
| Summary of participants with adverse events |  | From signing of the informed consent form to the end of the follow-up period (Week 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine addiction, TV-1380, Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)