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

Cocaine Addiction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887366
• Other study ID #: TV1380-COA-201
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2013
• Last updated: October 12, 2015
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
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
United States	Teva Investigational Site 10661	Boston	Massachusetts
United States	Teva Investigational Site 10658	Charleston	South Carolina
United States	Teva Investigational Site 10662	Columbus	Ohio
United States	Teva Investigational Site 10745	Las Vagas	Nevada
United States	Teva Investigational Site 10663	Los Angeles	California
United States	Teva Investigational Site 10667	Marlton	New Jersey
United States	Teva Investigational Site 10668	New Bedford	Massachusetts
United States	Teva Investigational Site 10664	North Miami	Florida
United States	Teva Investigational Site 10665	Oceanside	California
United States	Teva Investigational Site 10660	Pittsburgh	Pennsylvania
United States	Teva Investigational Site 10666	Salt Lake City	Utah
United States	Teva Investigational Site 10659	San Francisco	California
United States	Teva Investigational Site 10747	St Louis	Missouri
United States	Teva Investigational Site 10746	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine test for cocaine		Treatment Phase weeks 10 - 12	No
Secondary	Percent of urine samples that are considered negative for cocaine metabolites.		Treatment Phase Weeks 5 -12	No
Secondary	Summary of participants with adverse events		From signing of the informed consent form to the end of the follow-up period (Week 16)	Yes