Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence

In brief

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 be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.

Key facts

Study ID

NCT00218387

Run by

Medical University of South Carolina

People needed

123

Starts

2004-04-01

Expected to finish

2010-07-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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