- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00733967
Varenicline-Methamphetamine Interaction Study (2008)
25. juli 2012 opdateret af: Richard De La Garza, Baylor College of Medicine
A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline In Methamphetamine-Dependent Volunteers Receiving Methamphetamine
The primary aim of the study is to determine the safety and tolerability of treatment with Varenicline in methamphetamine-dependent volunteers.
The investigators also seek to determine the effects of treatment with Varenicline, as compared to placebo, on craving for methamphetamine or cigarettes following exposure to methamphetamine and smoking cues, respectively.
The effects of treatment with Varenicline, as compared to placebo, on subjective effects produced by administration of methamphetamine or placebo will be attempted to be determined.
Lastly, the investigators hope to determine the effects of treatment with Varenicline, as compared to placebo, on reinforcing effects produced by administration of methamphetamine or placebo.
Studieoversigt
Status
Trukket tilbage
Intervention / Behandling
Detaljeret beskrivelse
See Brief Summary
Undersøgelsestype
Interventionel
Fase
- Fase 1
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 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- English speaking volunteers who are not seeking treatment at the time of the study
- Be between 18-55 years of age
- Meet DSM-IV criteria for MA dependence
- Must be cigarette smokers, defined as smoking 10 or more cigarettes per day by self-report
- Have a self-reported history of using MA by the smoked or IV route and provide at least one MA-positive urine prior to admission
- Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 105-150 mm Hg systolic and 45-90 mm HG diastolic; this criterion must be met within 2 days of admission
- Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total Bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal
- Have a baseline EKG that demonstrates normal sinus rhythm, normal conduction (including QTc), and no clinically significant arrhythmias
- Have a medical history and brief physical examination demonstrating no clinically significant contradictions for study participation, in the judgment of the admitting physician or nurse practitioner and the principal investigator
Exclusion Criteria:
- Have any history or evidence suggestive of seizure disorder or brain injury
- Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure
- Have neurological or psychiatric disorders, such as: psychosis, bipolar illness or major depression as assessed by MINI; organic brain disease or dementia assessed by clinical interview; history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past three months assessed by MINI and/or current suicidal ideation/plan as assessed by MINI
- Have evidence of clinically significant heart disease or hypertension, as determined by the PI
- Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation
- Have asthma or currently use alpha or beta agonists, theophylline, or other sympathomimetics
- Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician or nurse practitioner would preclude safe and/or successful completion of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
Matching oral placebo capsules as control.
|
Matching oral placebo capsules as control.
Andre navne:
|
Aktiv komparator: Varenicline
See assigned interventions.
|
Varenicline (oral capsule): 0.5 mg once daily for 3 days; 0.5 mg twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
---|---|
Effects of varenicline and methamphetamine on cardiovascular measures.
|
The safety of MA administration during treatment will be assessed by reporting of adverse events (AEs), and using ECG recording, and heart rate and blood pressure measurements.
Digital 12-lead EKG will also be recorded prior to randomization.
Blood pressure and heart rate will be measured from 15 min prior to MA or placebo dosing until 2 h after dosing.
In addition, heart rate and blood pressure will be assessed throughout the inpatient portion of the protocol.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
---|---|
Effects of varenicline and methamphetamine on subjective measures
|
Efficacy will be assessed by measuring effects of treatment on subjective and reinforcing effects produced by administration of MA and craving produced by exposure to drug cues.
Other diagnostic measures and assessment instruments will be used to further characterize the study population.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard De La Garza, II, PhD, Baylor College of Medicine
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. januar 2008
Primær færdiggørelse (Faktiske)
1. august 2008
Studieafslutning (Faktiske)
1. august 2008
Datoer for studieregistrering
Først indsendt
11. august 2008
Først indsendt, der opfyldte QC-kriterier
11. august 2008
Først opslået (Skøn)
13. august 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-22707
- DPMC (Anden identifikator: NIDA)
- P50DA018185 (U.S. NIH-bevilling/kontrakt)
- 2P50DA018197-06 (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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