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Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions with Intravenous Cocaine - 1



Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions with Intravenous Cocaine - 1

For Condition: Infusions, Intravenous,Cocaine-Related Disorders,Drug Administration Schedule
Status: No longer recruiting
Sponsor(s): National Institute on Drug Abuse (NIDA) ,
Synopsis: Safety evaluations of cocaine treatment medication, modafinil: interactions with intravenous cocaine
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Dose Comparison
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Both
Protocol Entry Criteria: Please contact site for information 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
Total Enrollment: 12

Location and Contact Information:

Overall Study Official:
RobertMalcolm,  Principal Investigator,  Medical University of South Carolina

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


Additional Information:
Study ID Numbers:
  NIDA-CTO-0002-1; 
Study Start Date: June 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033046

Other Cocaine-Related Disorders Studies:
1. Drug Interaction Study with NS2359 and Cocaine in Cocaine Experienced Volunteers - 1

2. Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions with Intravenous Cocaine - 1

3. Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence - 1

Related Studies:

Other Cocaine-Related Disorders Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials

Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions with Intravenous Cocaine - 1

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