Cocaine AddictionPhase 2NCT01887366
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
A Phase 2 study testing TV-1380 150 mg and TV-1380 300 mg in people with Cocaine Addiction, run by Teva Branded Pharmaceutical Products R&D, Inc. at 19 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- TV-1380 150 mg and TV-1380 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jun 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States14 sites
Teva Investigational Site 10661
Boston, Massachusetts
Teva Investigational Site 10658
Charleston, South Carolina
Teva Investigational Site 10662
Columbus, Ohio
Teva Investigational Site 10745
Las Vagas, Nevada
Teva Investigational Site 10663
Los Angeles, California
Teva Investigational Site 10667
Marlton, New Jersey
Teva Investigational Site 10668
New Bedford, Massachusetts
Teva Investigational Site 10664
North Miami, Florida
Teva Investigational Site 10665
Oceanside, California
Teva Investigational Site 10660
Pittsburgh, Pennsylvania
Teva Investigational Site 10666
Salt Lake City, Utah
Teva Investigational Site 10659
San Francisco, California
Teva Investigational Site 10747
St Louis, Missouri
Teva Investigational Site 10746
Torrance, California
Spain5 sites
Teva Investigational Site 31064
Alicante
Teva Investigational Site 31063
Barcelona
Teva Investigational Site 31065
Barcelona
Teva Investigational Site 31069
Barcelona
Teva Investigational Site 31068
Madrid
About this study
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
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
- Being tested
- TV-1380 150 mg, TV-1380 300 mg, Placebo
- Keywords
- Cocaine addiction, TV-1380, Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-1380 150 mgDrug
Also called Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
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 mgDrug
Also called Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TV-1380 150 mg | Experimental | Not described Receives: Drug: TV-1380 150 mg |
| TV-1380 300 mg | Experimental | Not described Receives: Drug: TV-1380 300 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine test for cocaine
Measured: Treatment Phase weeks 10 - 12
Secondary outcomes (2)
Percent of urine samples that are considered negative for cocaine metabolites.
Measured: Treatment Phase Weeks 5 -12
Summary of participants with adverse events
Measured: From signing of the informed consent form to the end of the follow-up period (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887366
- Sponsor's protocol ID
- TV1380-COA-201
- Status last verified
- Oct 2015
- First submitted
- 24 Jun 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01887366
- Acronym / sponsor ID
- TV1380-COA-201
- Conditions
- Cocaine Addiction
- Keywords
- Cocaine addiction, TV-1380, Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TV-1380 150 mgAlso: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)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). | Drug | TV-1380 150 mg |
| TV-1380 300 mgAlso: Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)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. | Drug | TV-1380 300 mg |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
Urine test for cocaine
Time frame: Treatment Phase weeks 10 - 12
2 secondary outcomes
Percent of urine samples that are considered negative for cocaine metabolites.
Time frame: Treatment Phase Weeks 5 -12
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TV-1380 150 mg and TV-1380 300 mg in people with Cocaine Addiction, run by Teva Branded Pharmaceutical Products R&D, Inc. at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine test for cocaine (time frame: Treatment Phase weeks 10 - 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.