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- Essai clinique NCT00733967
Varenicline-Methamphetamine Interaction Study (2008)
25 juillet 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Retiré
Intervention / Traitement
Description détaillée
See Brief Summary
Type d'étude
Interventionnel
Phase
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
Matching oral placebo capsules as control.
|
Matching oral placebo capsules as control.
Autres noms:
|
Comparateur actif: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
---|---|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
---|---|
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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Richard De La Garza, II, PhD, Baylor College of Medicine
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2008
Achèvement primaire (Réel)
1 août 2008
Achèvement de l'étude (Réel)
1 août 2008
Dates d'inscription aux études
Première soumission
11 août 2008
Première soumission répondant aux critères de contrôle qualité
11 août 2008
Première publication (Estimation)
13 août 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 juillet 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juillet 2012
Dernière vérification
1 juillet 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H-22707
- DPMC (Autre identifiant: NIDA)
- P50DA018185 (Subvention/contrat des NIH des États-Unis)
- 2P50DA018197-06 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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