Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
NCT ID: NCT01887366
Last Updated: 2015-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2013-06-30
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of N-acetylcysteine in Treating Cocaine Dependent Individuals - 1
NCT00136825
TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
NCT02534454
An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects
NCT04996056
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
NCT00656357
Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
NCT00567320
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TV-1380 150 mg
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
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Teva Investigational Site 10664
North Miami, Florida, United States
Teva Investigational Site 10661
Boston, Massachusetts, United States
Teva Investigational Site 10668
New Bedford, Massachusetts, United States
Teva Investigational Site 10747
St Louis, Missouri, United States
Teva Investigational Site 10745
Las Vagas, Nevada, United States
Teva Investigational Site 10667
Marlton, New Jersey, United States
Teva Investigational Site 10662
Columbus, Ohio, United States
Teva Investigational Site 10660
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 10658
Charleston, South Carolina, United States
Teva Investigational Site 10666
Salt Lake City, Utah, United States
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TV1380-COA-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.