Modafinil, Sleep Architecture and Cocaine Relapse
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Modafinil; Cognitive Behavioral Therapy
Intervention description: Modafinil 400mg PO QDaily following up-titration for ~8weeks; Once weekly cognitive behavioral therapy for cocaine dependence
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: 114.0
Sex: All
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The medication modafinil has been shown to reduce cocaine use in some cocaine users. The
      investigators have shown that modafinil taken in the morning improves sleep in chronic
      cocaine users. The investigators hypothesize that the beneficial effects of modafinil in
      reducing cocaine use may be related to specific effects modafinil has on sleep. This study
      will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using
      cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-50 years of age;

          -  voluntary, written, informed consent;

          -  seeking but not currently enrolled in treatment for cocaine use;

          -  self-reported, current use of cocaine by smoked or intravenous route at least one time
             each week in the past month, with ≥1g used within a single 24-hour period and ≥3g used
             in the month;

          -  positive urine test for cocaine (benzoylecognine) at the time of screening and study
             start

          -  dependence on cocaine in the past year as measured by a score ≥ 3 on the Severity of
             Dependence Scale(Kaye and Darke, 2002);

          -  chronic use in the past year as determined by self-reported use in at least 9 of the
             past 12 months;

          -  lifetime diagnosis of cocaine dependence with a duration of at least 2 years as
             determined by the Structured Clinical Interview for DSM-IV (SCID).

        Exclusion Criteria:

          -  evidence of any neurological condition or a chronic medical condition including
             diabetes, cardiovascular disease or history of cardiac problems, HIV-seropositivity,
             liver disease, hypertension, asthma requiring daily medication, dementia, movement
             disorder, history of head trauma with loss of consciousness, sleep apnea, narcolepsy,
             restless leg syndrome, periodic limb movement disorder, REM sleep disorder,
             pharmacological treatment for insomnia of any type within the past 6 months, glaucoma,
             severe respiratory insufficiency, seizure disorder, or if in the past three months
             they have taken any medications that affect sleep, or are currently taking any
             regularly dosed prescription medication or any prn medication that is used on average
             more than 1x/week

          -  evidence of chronic sleep disorder including sleep apnea, narcolepsy, periodic limb
             movement disorder, restless leg syndrome as determined by medical history, Sleep
             Disorders Questionnaire(Douglass, 1994), or by polysomnography (following enrollment)

          -  current dependence on any drugs other than cocaine or nicotine or lifetime dependence
             on alcohol, benzodiazepines, or opiates, or any non-substance related Axis I disorder
             as determined by SCID

          -  current use of alcohol in excess of 3x/week AND 21 standard drinks/week in the past
             month or non-zero breathalyzer at screening or study start

          -  current use of cannabis in the past month

          -  positive urine toxicology test for opiates, methadone, amphetamines, barbiturates,
             benzodiazepines, PCP, methaquolone, and propoxyphene at the time of screening or
             positive test for any of those listed plus cannabis at the time of study start

          -  pregnancy as determined by serum β-HCG at screening or lactating per report

          -  females: unwillingness to use barrier contraceptives during sexual intercourse for the
             duration of the study

          -  known hypersensitivity to modafinil.