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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01887366
First received: June 24, 2013
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Cocaine Addiction
Drug: TV-1380 150 mg
Drug: TV-1380 300 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Urine test for cocaine [ Time Frame: Treatment Phase weeks 10 - 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of urine samples that are considered negative for cocaine metabolites. [ Time Frame: Treatment Phase Weeks 5 -12 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887366

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

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01887366     History of Changes
Other Study ID Numbers: TV1380-COA-201
Study First Received: June 24, 2013
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Cocaine addiction
TV-1380
Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Albunex
Cocaine
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Contrast Media
Diagnostic Uses of Chemicals
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014