Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2004 by National Institute on Drug Abuse (NIDA).
Recruitment status was Active, not recruiting
Information provided by:
National Institute on Drug Abuse (NIDA)
First received: April 5, 2002
Last updated: February 8, 2007
Last verified: May 2004
The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
Drug Administration Schedule
||Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
Primary Outcome Measures:
- pharmacokinetic parmaters at steady state
- BP, HR
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Additional criteria available during screening at the site
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033046
|Medical University of South Carolina
|Charleston, South Carolina, United States, 29425 742 |
||Robert Malcolm, M.D.
||Medical University of South Carolina
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 5, 2002
||February 8, 2007
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 31, 2015
Central Nervous System Agents
Central Nervous System Stimulants
Physiological Effects of Drugs