Modafinil Treatment for Cocaine-Dependent Individuals
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Low Dose Modafinil; High Dose Modafinil; Placebo
Intervention description: modafinil 200 mg/day; modafinil 400 mg/day; placebo 400 mg/day
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: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cocaine

Summary:

      Despite years of active research, there are still no approved medications for the treatment
      of cocaine dependence. The purpose of this study is to determine the effectiveness of
      modafinil in treating cocaine-dependent individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18 - 60 years;

          -  Current DSM-IV diagnosis of cocaine dependence

          -  Using at least $200 worth of cocaine within the past 30 days and having positive urine
             toxicology (BE) during screening;

          -  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

          -  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

          -  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 one of the medications under study,
             including propranolol, phenytoin, warfarin and diazepam;

          -  Currently taking any medication that could interact adversely with one of the
             medications under study, 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 enrollment

          -  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.