Overview

This trial is active, not recruiting.

Conditions cocaine-related disorders, drug administration schedule, infusions, intravenous
Treatment modafinil
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Start date June 2001
End date April 2002
Trial size 12 participants
Trial identifier NCT00033046, NCT00024752, NIDA-CTO-0002-1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
pharmacokinetic parmaters at steady state
time frame:
BP, HR
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
Principal investigator Robert Malcolm, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).