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

Study Overview
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Brief Summary
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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.

Detailed Description
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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, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence. A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine high will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.

Official Title
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CBT and Modafinil for Cocaine Addiction

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Modafinil
* Drug: Modafinil
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200mg Modafinil<br>200mg Modafinil | Drug: Modafinil<br>* 200mg Modafinil<br>* Other names: Provigil;|
| Experimental: 400mg Modafinil<br>400mg Modafinil | Drug: Modafinil<br>* 400mg Modafinil<br>* Other names: Provigil;|
| Placebo Comparator: Matching Placebo<br>Matching Placebo | Drug: Matching Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cocaine Non-use Days | Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels. | 8 weeks | 
| Percent of Participants With New Use | New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine Dependence