Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior

Study Overview
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Brief Summary
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The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.

Detailed Description
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The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an 8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in conjunction with Cognitive Behavioral Therapy (CBT).

Official Title
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Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Modafinil
* Drug: placebo
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 60 years; Current DSM-IV diagnosis of cocaine dependence; Using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding study entry (If subject was receiving inpatient substance abuse treatment within 30 days prior to screening, subject must have been using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding admission to inpatient treatment); 4.)Having a negative urine toxicology (BE) test during screening (no less than 5 days prior to randomization) and a negative urine toxicology (BE) test on the day of randomization. Repeat testing allowed until required negative BE results are obtained; Able to provide written informed consent and to comply with all study procedures; Women must be surgically sterile, at least two years postmenopausal, or, if of childbearing potential, be using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e. barrier method with spermicide, steroidal contraceptive [oral and implanted, including Depo-Provera, contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]). Exclusion Criteria: Currently dependent on any substance other than cocaine or nicotine; Current Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications; Serious medical illnesses, including but not limited to; uncontrolled hypertension, significant heart disease (including a history of myocardial infarction, angina, mitral valve prolapse, left ventricular hypertrophy, palpitations, and arrhythmia), hepatic disease, renal disease, or any serious, potentially life-threatening or progressive medical illness that may compromise patient safety or study conduct; Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment including, but not limited to: chemotherapeutic agents for neoplastic disease (i.e. methotrexate, vincristine, vinblastine, fluorouracil), agents used for parasitic infections, isoniazid, chlorambucil, dactinomycin, chloramphenicol, immunosuppressive and cytotoxic agents (i.e. cyclosporine, tacrolimus), indomethacin, protease inhibitors, amphotericin B, cephalosporins, aminoglycosides, interferon, and sulfonamides; Clinically significant abnormal laboratory values (see Appendix A); Has any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding); Known hypersensitivity or allergy to modafinil, or receiving chronic therapy with any medication that could interact adversely with modafinil, including propranolol, phenytoin, warfarin and diazepam; Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization; Taking or has taken an investigational drug within 60 days prior to randomization; If female and of child-bearing capacity, tests positive on a urine pregnancy test, is lactating, has had three or more days of amenorrhea beyond expected menses at the time of the first dose of study medication, is contemplating pregnancy in the next 6 months, or is not using an effective contraceptive method; Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60 days of study enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>modafinil plus CBT | Drug: Modafinil<br>* 300mg a day for 8 weeks<br>* Other names: Provigil;Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Weekly cognitive behavioral therapy sessions for a period of 8 weeks.<br>|
| Placebo Comparator: 2<br>placebo plus CBT | Drug: placebo<br>* placebo pills for 8 weeks<br>Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Weekly cognitive behavioral therapy sessions for a period of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants Reporting no Cocaine Craving | Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale. | 8 weeks | 
| Cocaine Use as Measured by Urine Drug Screen | The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence, hiv prevention