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Modafinil, Sleep, and Cognition in Cocaine Dependence

6 september 2012 uppdaterad av: Yale University
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

A relatively new treatment for the excessive daytime sleepiness (EDS) associated with inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective measures of daytime sleepiness under conditions of sleep restriction, while enhancing cognitive performance. At the same time, sleep quality does not appear to be affected significantly. Interestingly, recent clinical trials in cocaine-dependent populations suggest that modafinil reduces the relapse to cocaine use, by unknown mechanisms.

We propose to employ both subjective and objective measures of nocturnal sleep and daytime sleepiness, as well as measures of general cognitive performance and sleep-dependent memory consolidation, to explore potential mechanistic relationships between cocaine abstinence, EDS, and modafinil's efficacy in preventing cocaine relapse.

The following specific aims are proposed:

Specific Aim 1: To establish whether objective measures of poor nocturnal sleep (e.g., reduced total sleep time and sleep efficiency) that progressively characterize periods of sustained cocaine abstinence are also associated with objective evidence of excessive daytime sleepiness (EDS).

Specific Aim 2: To establish the ability of modafinil to reverse the excessive daytime sleepiness (EDS) and deficits in cognitive performance that characterize cocaine abstinence.

Specific Aim 3: To conduct a pilot study to determine whether the observed abnormalities in objective sleep, EDS, and/or cognitive function predict relapse to cocaine use and/or whether successful abstinence from cocaine is associated with normalization of the same.

Studietyp

Interventionell

Inskrivning (Faktisk)

44

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06519
        • Connecticut Mental Health Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: I
Modafinil 400mg orally everyday for 16 days
Läkemedel: Modafinil
Modafinil 400mg orally every day for 16 days
Andra namn:
  • Provigil
Placebo-jämförare: II
Placebo orally everyday for 16 days
Läkemedel: Placebo
Placebo orally everyday for 16 days

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total Sleep Time (Minutes)
Tidsram: After 1 Week

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)
Tidsram: After 2 Weeks

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)
Tidsram: After 3 Weeks

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)
Tidsram: After 1 Week
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)
Tidsram: After 2 Weeks
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)
Tidsram: After 3 Weeks
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Sleep Quality on Visual Analog Scale (Millimeters)
Tidsram: After 1 Week

Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.
After 1 Week
Overall Sleep Quality on Visual Analog Scale (Millimeters)
Tidsram: After 2 Weeks

Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.
After 2 Weeks
Overall Sleep Quality on Visual Analog Scale (Millimeters)
Tidsram: After 3 Weeks

Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.
After 3 Weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Yale University

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Utredare

  • Huvudutredare: Peter T Morgan, MD, PhD, Yale University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2006

Primärt slutförande (Faktisk)

1 februari 2009

Avslutad studie (Faktisk)

1 februari 2009

Studieregistreringsdatum

Först inskickad

21 december 2007

Först inskickad som uppfyllde QC-kriterierna

27 december 2007

Första postat (Uppskatta)

28 december 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

14 september 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 september 2012

Senast verifierad

1 september 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 0607001659
  • R01DA011744 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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