Modafinil, Sleep Architecture and Cocaine Relapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01137396
First received: June 3, 2010
Last updated: March 24, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Cocaine Dependence
Drug: Modafinil
Behavioral: Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil, Sleep Architecture and Cocaine Relapse

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • %Cocaine Free Urines [ Time Frame: 3x/week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in N3 (Slow-wave) Sleep Time [ Time Frame: change from week 1 to week 2 of inpatient treatment ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: April 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modafinil Drug: Modafinil
Modafinil 400mg PO QDaily following up-titration for ~8weeks
Behavioral: Cognitive Behavioral Therapy
Once weekly cognitive behavioral therapy for cocaine dependence
Placebo Comparator: Placebo Behavioral: Cognitive Behavioral Therapy
Once weekly cognitive behavioral therapy for cocaine dependence

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137396

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Peter Morgan, MD, PhD Yale University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01137396     History of Changes
Other Study ID Numbers: 0911005989  DA011744-08 
Study First Received: June 3, 2010
Results First Received: March 24, 2016
Last Updated: March 24, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on July 28, 2016