Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine

The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Study Type

Interventional

Enrollment

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425 742
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.

Exclusion Criteria:

Additional criteria available during screening at the site

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
BP, HR
pharmacokinetic parmaters at steady state

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Robert Malcolm, M.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion

April 1, 2002

Study Registration Dates

First Submitted

April 5, 2002

First Submitted That Met QC Criteria

April 5, 2002

First Posted (Estimate)

April 8, 2002

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

May 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTO-0002-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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