A Multi-Center Trial of Nepicastat for Cocaine Dependence

NCT01704196 | Completed Phase 2 Results DMC

• 1 other identifier: NIDA/VA CS#1031
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 10

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Abstinence (Weeks 10 - 11)

  Number of subjects that abstained from cocaine from weeks 10 through 11

  Weeks 10 - 11

Secondary Outcomes (1)

• Reduction in Use (Weeks 1 - 11)

  Baseline through week 11

Study Arms (2)

Nepicastat

ACTIVE COMPARATOR

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

Drug: Nepicastat

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Nepicastat DRUG

120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.

Nepicastat

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Please contact the study site for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (10)

Matrix Institute on Addictions

Los Angeles, California, 90016, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

VA Medical Center - Denver, CO

Denver, Colorado, 80220, United States

Location

Mountain Manor Treatment Center at Baltimore

Baltimore, Maryland, 21229, United States

Location

Pacific Institute for Research and Evaluation

Albuquerque, New Mexico, 87102, United States

Location

Columbia University Medical Center

New York, New York, 10019, United States

Location

Cincinnati Addiction Research Center

Cincinnati, Ohio, 45220, United States

Location

University of Pennsylvania - Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

George E. Wahlen VA Medical Center

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

nepicastat

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Liza Zeinert
• Organization: National Institute on Drug Abuse

liza.zeinert@nih.gov

301-443-1138

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: October 11, 2012
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 18, 2017
• Results First Posted: May 18, 2017

Record last verified: 2017-04

Locations

US (10)