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

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ClinicalTrials.gov Identifier: NCT01887366
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Drug: TV-1380 150 mg Drug: TV-1380 300 mg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: TV-1380 150 mg 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).
Other Name: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Experimental: TV-1380 300 mg 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.
Other Name: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Placebo Comparator: Placebo 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.


Outcome Measures
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Primary Outcome Measures :
  1. Urine test for cocaine [ Time Frame: Treatment Phase weeks 10 - 12 ]

Secondary Outcome Measures :
  1. Percent of urine samples that are considered negative for cocaine metabolites. [ Time Frame: Treatment Phase Weeks 5 -12 ]
  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887366


Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT01887366    
Other Study ID Numbers: TV1380-COA-201
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: October 2015
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Cocaine addiction
TV-1380
Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders