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

Primary Purpose

Cocaine Addiction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TV-1380 150 mg
TV-1380 300 mg
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring Cocaine addiction, TV-1380, Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teva Investigational Site 10663
  • Teva Investigational Site 10665
  • Teva Investigational Site 10659
  • Teva Investigational Site 10746
  • Teva Investigational Site 10664
  • Teva Investigational Site 10661
  • Teva Investigational Site 10668
  • Teva Investigational Site 10747
  • Teva Investigational Site 10745
  • Teva Investigational Site 10667
  • Teva Investigational Site 10662
  • Teva Investigational Site 10660
  • Teva Investigational Site 10658
  • Teva Investigational Site 10666
  • Teva Investigational Site 31064
  • Teva Investigational Site 31063
  • Teva Investigational Site 31065
  • Teva Investigational Site 31069
  • Teva Investigational Site 31068

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TV-1380 150 mg

TV-1380 300 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Urine test for cocaine

Secondary Outcome Measures

Percent of urine samples that are considered negative for cocaine metabolites.
Summary of participants with adverse events

Full Information

First Posted
June 24, 2013
Last Updated
October 12, 2015
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01887366
Brief Title
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction
Keywords
Cocaine addiction, TV-1380, Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TV-1380 150 mg
Arm Type
Experimental
Arm Title
TV-1380 300 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TV-1380 150 mg
Other Intervention Name(s)
Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
TV-1380 300 mg
Other Intervention Name(s)
Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urine test for cocaine
Time Frame
Treatment Phase weeks 10 - 12
Secondary Outcome Measure Information:
Title
Percent of urine samples that are considered negative for cocaine metabolites.
Time Frame
Treatment Phase Weeks 5 -12
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Teva Investigational Site 10663
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10665
City
Oceanside
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10659
City
San Francisco
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10746
City
Torrance
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10664
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10661
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 10668
City
New Bedford
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 10747
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10745
City
Las Vagas
State/Province
Nevada
Country
United States
Facility Name
Teva Investigational Site 10667
City
Marlton
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10662
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10660
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10658
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10666
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 31064
City
Alicante
Country
Spain
Facility Name
Teva Investigational Site 31063
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 31065
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 31069
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 31068
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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