Modafinil, Sleep Architecture and Cocaine Relapse

Yale University

Status and phase

Completed

Phase 2

Conditions

Cocaine Dependence

Treatments

Drug: Modafinil

Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01137396

DA011744-08

0911005989

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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.