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

NCT01887366 | Completed Phase 2

• 1 other identifier: TV1380-COA-201
• Study Type: interventional
• Target: 208
• Locations: 2 countries
• Sites: 19

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.

Conditions

Cocaine Addiction

Keywords

Cocaine addiction; TV-1380; Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

Outcome Measures

Primary Outcomes (1)

• Urine test for cocaine

  Treatment Phase weeks 10 - 12

Secondary Outcomes (2)

• 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)

Study Arms (3)

TV-1380 150 mg

EXPERIMENTAL

Drug: TV-1380 150 mg

TV-1380 300 mg

EXPERIMENTAL

Drug: TV-1380 300 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TV-1380 150 mg DRUG

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).

Also known as: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

TV-1380 150 mg

TV-1380 300 mg DRUG

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.

Also known as: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)

TV-1380 300 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (19)

Teva Investigational Site 10663

Los Angeles, California, United States

Location

Teva Investigational Site 10665

Oceanside, California, United States

Location

Teva Investigational Site 10659

San Francisco, California, United States

Location

Teva Investigational Site 10746

Torrance, California, United States

Location

Teva Investigational Site 10664

North Miami, Florida, United States

Location

Teva Investigational Site 10661

Boston, Massachusetts, United States

Location

Teva Investigational Site 10668

New Bedford, Massachusetts, United States

Location

Teva Investigational Site 10747

St Louis, Missouri, United States

Location

Teva Investigational Site 10745

Las Vagas, Nevada, United States

Location

Teva Investigational Site 10667

Marlton, New Jersey, United States

Location

Teva Investigational Site 10662

Columbus, Ohio, United States

Location

Teva Investigational Site 10660

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 10658

Charleston, South Carolina, United States

Location

Teva Investigational Site 10666

Salt Lake City, Utah, United States

Location

Teva Investigational Site 31064

Alicante, Spain

Location

Teva Investigational Site 31063

Barcelona, Spain

Location

Teva Investigational Site 31065

Barcelona, Spain

Location

Teva Investigational Site 31069

Barcelona, Spain

Location

Teva Investigational Site 31068

Madrid, Spain

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

TV-1380

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 5, 2015

Record last verified: 2015-10

Locations

ES (5); US (14)