Overview

This trial is active, not recruiting.

Condition cocaine addiction
Treatments tv-1380 150 mg, tv-1380 300 mg, placebo
Phase phase 2
Sponsor Teva Pharmaceutical Industries
Start date June 2013
End date September 2014
Trial size 210 participants
Trial identifier NCT01887366, TV1380-COA-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
tv-1380 150 mg 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).
(Experimental)
tv-1380 300 mg 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.
(Placebo Comparator)
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.

Primary Outcomes

Measure
Urine test for cocaine
time frame: Treatment Phase weeks 10 - 12

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.