Completed

Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Nepicastat

+ Placebo

Drug
Who is being recruted

Mental Disorders+1

+ Substance-Related Disorders

+ Chemically-Induced Disorders

From 18 to 99 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: May 18, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01704196
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: May 18, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

179 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersChemically-Induced DisordersCocaine-Related Disorders

Criteria

6 inclusion criteria required to participate
Be at least 18 years of age
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 able to understand and provide written informed consent
Show More Criteria
1 exclusion criteria prevent from participating
Please contact the study site for more information

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Matrix Institute on Addictions

Los Angeles, United StatesOpen Matrix Institute on Addictions in Google Maps

VA San Diego Healthcare System

San Diego, United States

VA Medical Center - Denver, CO

Denver, United States

Mountain Manor Treatment Center at Baltimore

Baltimore, United States
Completed10 Study Centers