Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Modafinil; Modafinil; Matching Placebo
Intervention description: 200mg Modafinil; 400mg Modafinil; Matching Placebo
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cocaine Dependence

Summary:

      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.
    

Eligibility criteria:

        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