Modafinil, Sleep Architecture and Cocaine Relapse

Cocaine Dependence Clinical Trial

Official title:

Modafinil, Sleep Architecture and Cocaine Relapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01137396
• Other study ID #: 0911005989
• Secondary ID: DA011744-08
• Status: Recruiting
• Phase: Phase 2
• First received: June 3, 2010
• Last updated: January 21, 2015
• Start date: April 2010
• Est. completion date: February 2015

Study information

• Verified date: July 2012
• Source: Yale University
• Contact: Erica Forselius, B.A.
• Phone: 203-974-7545
• Email: erica.forselius[@]yale.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 ß-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence

Intervention

Drug:
• Modafinil
Modafinil 400mg PO QDaily following up-titration for ~8weeks

Behavioral:
• Cognitive Behavioral Therapy
Once weekly cognitive behavioral therapy for cocaine dependence

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cocaine-free urines		3x/week	No
Secondary	Polysomnographically measured sleep		5 times over 8 weeks	No