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A Multi-Center Trial of Nepicastat for Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nepicastat
Placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Matrix Institute on Addictions
  • VA San Diego Healthcare System
  • VA Medical Center - Denver, CO
  • Mountain Manor Treatment Center at Baltimore
  • Pacific Institute for Research and Evaluation
  • Columbia University Medical Center
  • Cincinnati Addiction Research Center
  • University of Pennsylvania - Treatment Research Center
  • Michael E. DeBakey VA Medical Center
  • George E. Wahlen VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nepicastat

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Abstinence (Weeks 10 - 11)
Number of subjects that abstained from cocaine from weeks 10 through 11

Secondary Outcome Measures

Reduction in Use (Weeks 1 - 11)
Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11

Full Information

First Posted
September 17, 2012
Last Updated
April 7, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01704196
Brief Title
A Multi-Center Trial of Nepicastat for Cocaine Dependence
Official Title
Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nepicastat
Arm Type
Active Comparator
Arm Description
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Intervention Type
Drug
Intervention Name(s)
Nepicastat
Intervention Description
120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Abstinence (Weeks 10 - 11)
Description
Number of subjects that abstained from cocaine from weeks 10 through 11
Time Frame
Weeks 10 - 11
Secondary Outcome Measure Information:
Title
Reduction in Use (Weeks 1 - 11)
Description
Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11
Time Frame
Baseline through week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90016
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
VA Medical Center - Denver, CO
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Mountain Manor Treatment Center at Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Pacific Institute for Research and Evaluation
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cincinnati Addiction Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University of Pennsylvania - Treatment Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
George E. Wahlen VA Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

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A Multi-Center Trial of Nepicastat for Cocaine Dependence

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