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Modafinil, Sleep Architecture and Cocaine Relapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01137396
First received: June 3, 2010
Last updated: July 19, 2012
Last verified: July 2012

June 3, 2010
July 19, 2012
April 2010
February 2015   (final data collection date for primary outcome measure)
Number of cocaine-free urines [ Time Frame: 3x/week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01137396 on ClinicalTrials.gov Archive Site
Polysomnographically measured sleep [ Time Frame: 5 times over 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modafinil, Sleep Architecture and Cocaine Relapse
Modafinil, Sleep Architecture and Cocaine Relapse

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: Modafinil
    Modafinil 400mg PO QDaily following up-titration for ~8weeks
  • Behavioral: Cognitive Behavioral Therapy
    Once weekly cognitive behavioral therapy for cocaine dependence
  • Experimental: Modafinil
    Interventions:
    • Drug: Modafinil
    • Behavioral: Cognitive Behavioral Therapy
  • Placebo Comparator: Placebo
    Intervention: Behavioral: Cognitive Behavioral Therapy
Angarita GA, Canavan SV, Forselius E, Bessette A, Pittman B, Morgan PT. Abstinence-related changes in sleep during treatment for cocaine dependence. Drug Alcohol Depend. 2014 Jan 1;134:343-7. doi: 10.1016/j.drugalcdep.2013.11.007. Epub 2013 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
25 Years to 50 Years
No
Contact: Erica Forselius, B.A. 203-974-7545 erica.forselius@yale.edu
Contact: Jennifer Vollmer, B.A. 203-974-7545 jennifer.vollmer@yale.edu
United States
 
NCT01137396
0911005989, DA011744-08
No
Yale University
Yale University
Not Provided
Principal Investigator: Peter Morgan, MD, PhD Yale University
Yale University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP