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

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Teva Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Cocaine Addiction

Treatments

Drug: TV-1380 300 mg
Drug: TV-1380 150 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01887366
TV1380-COA-201

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

208 participants in 3 patient groups, including a placebo group

TV-1380 150 mg
Experimental group
Treatment:
Drug: TV-1380 150 mg
TV-1380 300 mg
Experimental group
Treatment:
Drug: TV-1380 300 mg
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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