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.
This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with
current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks.
Participants will be randomly assigned to receive a single morning dose of low-dose modafinil
(200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition,
each week participants will receive manual-guided cognitive behavioral therapy at the
Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo
will be abruptly discontinued. One week following, an end of medication evaluation will
occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after
initial randomization. Efforts will be made to continue evaluation of subjects who decide to
discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure
cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be
evaluated.
Inclusion Criteria:
- Current DSM-IV diagnosis of cocaine dependence
- Cocaine use of at least $200 worth within the 30 days prior to enrollment
- Positive urine toxicology test during initial screening
- Women of childbearing potential must use a medically accepted method of contraception
prior to and throughout the study, as well as for at least 30 days after the last dose
of the study drug; acceptable methods of contraception include 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, such as uncontrolled hypertension, significant heart
disease (including a history of myocardial infarction, angina, mitral valve prolapse,
left ventricular hypertrophy, palpitations, and arrhythmia), liver disease, kidney
disease, or any serious, potentially life-threatening or progressive medical illness
that may compromise patient safety or study conduct
- Use of a drug with known potential for toxicity to a major organ system within the
month prior to entering treatment; examples of such drugs include chemotherapeutic
agents for neoplastic disease (e. g., methotrexate, vincristine, vinblastine,
fluorouracil), agents used for parasitic infections, isoniazid, chlorambucil,
dactinomycin, chloramphenicol, immunosuppressive and cytotoxic agents (e. g.,
cyclosporine, tacrolimus), indomethacin, protease inhibitors, amphotericin B,
cephalosporins, aminoglycosides, interferon, and sulfonamides
- Clinically significant abnormal laboratory values
- History of or current diagnoses of gastrointestinal, liver, or kidney disease, which
may result in altered metabolism or excretion of the study medication
- History of major gastrointestinal tract surgery, gastrectomy, gastrostomy, or bowel
resection
- History of chronic gastrointestinal disorders (e. g., ulcerative colitis, regional
enteritis, gastrointestinal bleeding)
- Known hypersensitivity or allergy to modafinil
- Currently taking any medication that could interact adversely with one of the
medications under study, including propranolol, phenytoin, warfarin and diazepam
- Use of monoamine oxidase inhibitors (MAOI) within 30 days prior to enrollment
- Taking or has taken an investigational drug within 60 days prior to enrollment
- Women of childbearing potential who test positive on a urine pregnancy test, are
breastfeeding, have had three or more days of amenorrhea beyond expected menses at the
time of the first dose of study medication, are contemplating pregnancy in the next 6
months, or are not using adequate contraception
- Use of an investigational drug or any opiate-substitute treatment (e. g., methadone,
LAAM, buprenorphine) within 60 days prior to enrollment
