Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Modafinil; placebo; Cognitive Behavioral Therapy (CBT)
Intervention description: 300mg a day for 8 weeks; placebo pills for 8 weeks; Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cocaine dependence; hiv prevention

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. 18 - 60 years;

          2. Current DSM-IV diagnosis of cocaine dependence;

          3. 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;

          4. Able to provide written informed consent and to comply with all study procedures;

          5. 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:

          1. Currently dependent on any substance other than cocaine or nicotine;

          2. Current Neurological or psychiatric disorders, such as psychosis, bipolar illness,
             organic brain disease, dementia, or any diseases that require psychotropic
             medications;

          3. 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;

          4. 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;

          5. Clinically significant abnormal laboratory values (see Appendix A);

          6. 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);

          7. 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;

          8. Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;

          9. Taking or has taken an investigational drug within 60 days prior to randomization;

         10. 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;

         11. Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60
             days of study enrollment.