NCT00582491

Brief Summary

Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience Research Unit and involves subjective and objective tests of sleep, sleepiness, attention, and learning. During inpatient admission subjects will take modafinil or placebo. For follow-up, subjects will return to the CNRU for one night and again participate in objective tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will decrease subject and objective measures of sleepiness and will promote attention and learning in cocaine dependent persons.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

September 6, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

2.5 years

First QC Date

December 21, 2007

Results QC Date

August 6, 2012

Last Update Submit

September 6, 2012

Conditions

Cocaine DependenceSubstance-induced Sleep DisorderSubstance-induced Cognitive Disorder

Keywords

ModafinilSleepCognitionCocaine Dependence

Outcome Measures

Primary Outcomes (6)

  • Total Sleep Time (Minutes)

    Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

    After 1 Week

  • Total Sleep Time (Minutes)

    Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

    After 2 Weeks

  • Total Sleep Time (Minutes)

    Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

    After 3 Weeks

  • Time Spent in Sleep Stage 3 (Minutes)

    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

    After 1 Week

  • Time Spent in Sleep Stage 3 (Minutes)

    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

    After 2 Weeks

  • Time Spent in Sleep Stage 3 (Minutes)

    Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

    After 3 Weeks

Secondary Outcomes (3)

  • Overall Sleep Quality on Visual Analog Scale (Millimeters)

    After 1 Week

  • Overall Sleep Quality on Visual Analog Scale (Millimeters)

    After 2 Weeks

  • Overall Sleep Quality on Visual Analog Scale (Millimeters)

    After 3 Weeks

Study Arms (2)

I

EXPERIMENTAL

Modafinil 400mg orally everyday for 16 days

Drug: Modafinil

II

PLACEBO COMPARATOR

Placebo orally everyday for 16 days

Drug: Placebo

Interventions

ModafinilDRUG

Modafinil 400mg orally every day for 16 days

Also known as: Provigil
I
PlaceboDRUG

Placebo orally everyday for 16 days

II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female individuals, ages 18-65, meeting current DSM-IV criteria for cocaine dependence. Documented positive urine toxicology screen for cocaine at intake and regular 3 times more weekly use of cocaine.
  • Subject has voluntarily given informed consent and signed the informed consent document(s).
  • Able to read English and complete study evaluations.

You may not qualify if:

  • Use of prescription medication in the past 6 months indicating a medical or psychiatric condition that in the opinion of the PI would interfere with study participation (e.g. hypertension, severe renal or hepatic disease, HIV, primary psychotic disorder, primary mood disorder, primary sleep disorder).
  • Meeting DSM-IV criteria for dependence on any substance other than cocaine and nicotine.
  • Significant underlying medical or psychiatric conditions or hypersensitivity to modafinil that in the opinion of the PI would interfere with study participation.
  • Abstinence from cocaine for more than one week prior to inpatient admission.
  • Positive urine or serum pregnancy test.
  • Women who are pregnant or lactating, or not using a reliable method of birth control.
  • (For subjects completing the fMRI portion of the study) Presence of or history indicative of ferromagnetic metal in their bodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Peter Morgan, MD, PhD
Organization
Yale University School of Medicine
Peter.Morgan@yale.edu
203-974-7515

Study Officials

  • Peter T Morgan, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

August 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 14, 2012

Results First Posted

September 6, 2012

Record last verified: 2012-09

Locations

US(1)