Status:
COMPLETED
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may ...
Detailed Description
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, la...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Seeking treatment for cocaine dependence
- Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
- If female, willing to use effective contraception throughout the study
- Lives within 50 miles of the research center and has reliable transportation
- Exclusion criteria:
- Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
- Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
- Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
- Recent suicidal or homicidal attempts within 60 days of study entry
- Suicidal or homicidal ideation within 30 days of study entry
- Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)
- Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
- Required by the court to obtain treatment for cocaine dependence
- Not seeking treatment for cocaine dependence
- Participated in cocaine treatment (clinical or research) within 30 days of study entry
- Anticipating elective surgery or hospitalization within 20 weeks of study entry
- Known or suspected hypersensitivity to modafinil
- Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants
- Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine
- Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways
- Pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00218387
Start Date
April 1 2004
End Date
July 1 2010
Last Update
April 10 2019
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425