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

October 12, 2015 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Teva Investigational Site 31064
      • Barcelona, Spain
        • Teva Investigational Site 31063
      • Barcelona, Spain
        • Teva Investigational Site 31065
      • Barcelona, Spain
        • Teva Investigational Site 31069
      • Madrid, Spain
        • Teva Investigational Site 31068
  • United States
    • California
      • Los Angeles, California, United States
        • Teva Investigational Site 10663
      • Oceanside, California, United States
        • Teva Investigational Site 10665
      • San Francisco, California, United States
        • Teva Investigational Site 10659
      • Torrance, California, United States
        • Teva Investigational Site 10746
    • Florida
      • North Miami, Florida, United States
        • Teva Investigational Site 10664
    • Massachusetts
      • Boston, Massachusetts, United States
        • Teva Investigational Site 10661
      • New Bedford, Massachusetts, United States
        • Teva Investigational Site 10668
    • Missouri
      • St Louis, Missouri, United States
        • Teva Investigational Site 10747
    • Nevada
      • Las Vagas, Nevada, United States
        • Teva Investigational Site 10745
    • New Jersey
      • Marlton, New Jersey, United States
        • Teva Investigational Site 10667
    • Ohio
      • Columbus, Ohio, United States
        • Teva Investigational Site 10662
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Teva Investigational Site 10660
    • South Carolina
      • Charleston, South Carolina, United States
        • Teva Investigational Site 10658
    • Utah
      • Salt Lake City, Utah, United States
        • Teva Investigational Site 10666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • 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 Names:
  • Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV1380-COA-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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