- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01204723
Medications Development for the Treatment of Cannabis Related Disorders (MTC)
31. maj 2012 opdateret af: University of Virginia
The primary objective of this application is to test the neurobehavioral mechanisms and effects of aprepitant as a new cessation agent for cannabis, tobacco or both.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Stress (emotional, physical, social) facilitates drug seeking behavior through the activation of the HPA axis, autonomic nervous system, and brain DA systems.
Furthermore, alterations within several neuropeptide systems (CRF, Substance P, and others) also contribute to the role of stress in addiction.
Central to this project is that anxiety and stress responses are modulated by substance P and its preferred target, the NK1 receptor.
Therefore the aim of this pilot clinical trial is to determine the safety and efficacy of aprepitant (a neurokinin 1 (NK1) receptor antagonist).
We hypothesize that the NK1 receptor antagonist, aprepitant, will be safe, tolerable and efficacious at reducing the withdrawal symptoms, cue craving, and reinforcement value for both cannabis and tobacco resulting from the cessation of either or both drugs.
We will assess this hypothesis in the context of a carefully controlled human laboratory study in which subjects (N=72) will be randomized in a 3 x 2 factorial design to one of 3 behavioral conditions; a) withdrawn from both substances, b) withdrawn from tobacco only, or c) withdrawn from cannabis only, and to receive one of 2 medication dose conditions: placebo or aprepitant (160 mg/day).
Medication will be administered for 5 days, followed by a cue challenge, choice procedure, and then a consequence (i.e., oral cannabis or a cigarette or money) also on day 5.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
63
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
- Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Center for Addiction Education and Treatment (UVA CARE)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Must meet DSM-IV/ICD-10 criteria for cannabis abuse or dependence
- Must be non-treatment seeking individuals
- Participant does not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) dependence on a substance other than alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
- No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data
- Not currently taking other medications (with the exception of oral contraceptives) that would preclude safe participation in this study
- Must test negative for pregnancy prior to inclusion
- females using birth control pills must agree to use a condom during intercourse for 1 month after participation in study because the study medication will decrease the effectiveness of the birth control pill rendering it ineffective
- Should be in general good health
- No evidence of recent use of other illicit drugs on a urine toxicity screen prior to admission
Exclusion Criteria:
- Major current (within last 90 days) Axis I psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia)
- Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, cancer, epilepsy, kidney disease)
- Current, repeated illicit drug use (other than marijuana)
- Subject is breastfeeding or pregnant
- Concurrent therapy with drugs known to inhibit CYP3A4 activity
- Request for drug treatment
- Current parole or probation
- Recent history of significant violent or suicide behavior
- Allergic to sesame oil
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Behavioral Condition 1
Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
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Placebo Aprepitant 0 mg once daily for 5 days
Active Aprepitant 160 mg once daily for 5 days
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Eksperimentel: Behavioral Condition 2
Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
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Placebo Aprepitant 0 mg once daily for 5 days
Active Aprepitant 160 mg once daily for 5 days
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Eksperimentel: Behavioral Condition 3
Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
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Placebo Aprepitant 0 mg once daily for 5 days
Active Aprepitant 160 mg once daily for 5 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
Tidsramme: collected on each study day
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Subjective experience of withdrawal symptoms for cannabis, tobacco, and both (eg: Irritability, Sleep difficulty, Chills, Nervousness)
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collected on each study day
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"craving" measured using the Marijuana craving questionaire and the tobacco craving questionaire
Tidsramme: collected on each study day
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Subjective measures of craving for cannabis, tobacco, and both Questionaires are anchored with strongly disagree to strongly agree (1-7)
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collected on each study day
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reinforcing effects, as measured using the Multiple Choice Questionaire
Tidsramme: collected each day of study
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Reinforcement value of cannabis and tobacco as measured by preference for money over the administration of either drug; questionaire has 70 questions and money value vs. drug ranges from 25 cents to 25 dollars 1-70.
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collected each day of study
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
sleep quality
Tidsramme: collected on each study day
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A VAS sleep questionnaire will be used each morning to assess daily sleep quality.
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collected on each study day
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Neurocognitive Function
Tidsramme: collected on days 1-4 of the study
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The purpose of examining the neurocognitive function of our participants on days 1-4 is to examine the safety of the co-administration of aprepitant at 160 mg/day with oral THC (dronabinol 10 mg) on brain function.
Tasks used are the DSST - The Digit Symbol Substitution Test measures the learning of integrating visual and motor skills, and the SRTT- The Simple reaction Time Task is a well validated computerized test for assessing the effects of psychoactive drugs on performance.
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collected on days 1-4 of the study
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Tidsramme: each day of study
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Blood pressure, pulse, and a Systematic Assessment For Treatment Emergent Events (SAFTEE) are collected daily.
Electrocardiograms (EKGs) are collected at baseline and discharge.
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each day of study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Heather M Haughey, Ph.D., University of Virginia School of Medicine, Dept. Psychiatry and Neurobehavioral Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2009
Primær færdiggørelse (Faktiske)
1. januar 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
14. september 2010
Først indsendt, der opfyldte QC-kriterier
15. september 2010
Først opslået (Skøn)
17. september 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Patologiske processer
- Tilbagevenden
- hash
- Nikotin afhængighed
- Narkotiske antagonister
- Psykiske lidelser
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Stof-relaterede lidelser
- Stoffet P
- Terapeutiske anvendelser
- Psykotropiske stoffer
- Stofabstinenssyndrom
- Analgetika
- Sygdomsegenskaber
- Neurotransmittermidler
- Tetrahydrocannabinol
- Molekylære mekanismer for farmakologisk virkning
- Nikotin abstinenser
- Misbrug af marihuana
- Analgetika, ikke-narkotisk
- Forstyrrelser af miljømæssig oprindelse
- neurokinin Receptor
- NK1 Receptor antagonist
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Tobaksbrugsforstyrrelse
- Misbrug af marihuana
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antiemetika
- Gastrointestinale midler
- Neurokinin-1-receptorantagonister
- Aprepitant
- Fosaprepitant
Andre undersøgelses-id-numre
- 14392
- R01DA027131 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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