A Multi-Center Trial of Nepicastat for Cocaine Dependence

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: Nepicastat; Drug: Placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT01704196

NIDA/VA CS#1031

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.

Enrollment: 179 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 18 years of age
• Is seeking treatment for cocaine dependence
• Is able to understand and provide written informed consent
• Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
• If female, agrees to use an acceptable method of birth control
• Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study

Exclusion criteria

• Please contact the study site for more information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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179 participants in 2 patient groups, including a placebo group

Nepicastat

Active Comparator group

Description:

Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks

Treatment:

Drug: Nepicastat

Placebo

Placebo Comparator group

Description:

Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.

Treatment:

Drug: Placebo