Research and Clinical Trials on Alprazolam (Xanax)

By Dr Greg Mulhauser
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This list of current clinical research trials on Alprazolam (Xanax) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

Alprazolam (Xanax) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Alprazolam (Xanax).

 

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Current Research Literature on Alprazolam (Xanax)

Here are abstracts for some of the latest research articles to have appeared on Alprazolam (Xanax):

Development and validation of a liquid chromatography-atmospheric pressure photoionization-mass spectrometry method for the quantification of alprazolam, flunitrazepam, and their main metabolites in haemolysed blood.

J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Dec 6;
Marchi I, Schappler J, Veuthey JL, Rudaz S
A LC-APPI-MS method was developed and validated for the detection of alprazolam, flunitrazepam and their major metabolites in haemolysed blood. Samples were diluted with water (2:1, v:v) and extracted with a hydrophobic-lipophilic balanced copolymer. The method was fully validated according to ICH guidelines and SFSTP protocols. Deuterated internal standards of both parent drugs were used and good quantitative performance was achieved in terms of trueness and precision (repeatability and intermediate precision) since accuracy profiles were achieved within the acceptance limits (+/-30% for biological samples). The LC-APPI-MS method was linear over the concentration range of 1-1000 and 3-1000ng/mL, for alprazolam and flunitrazepam, respectively. Lower limits of quantification as low as 1ng/mL in haemolysed blood were reached and the method was successfully applied to the quantification of alprazolam, flunitrazepam and their major metabolites in real toxicological samples.

Alprazolam Intercalates into DNA.

J Biomol Struct Dyn. 2009 Feb; 26(4): 421-430
Saha B, Mukherjee A, Santra CR, Chattopadhyay A, Ghosh AN, Choudhuri U, Karmakar P
In vitro interaction of a benzodiazepine group of drugs Alprazolam (Alp), a hypnotic and tranquilizer, with DNA was studied by various methods. Absorption spectrophotometric study showed that Alp binds strongly with supercoiled pUC 19 DNA and the calculated binding constant is 8.245 x 10(3) M(-1) in 10 mM Tris-Cl buffer, pH 7.4. Spectrofluorometric study showed that ethidium bromide induced DNA fluorescence intensity was reduced completely after addition of Alp. But Alp did not interfere with the interaction of Hoechst 33258, a DNA minor groove binder, with plasmid DNA. Circular dichroic spectroscopic study showed that with the gradual increase in Alp concentrations, both the positive and the negative peaks of DNA were gradually decreased and at higher concentrations of Alp (60 muM and 80 muM), the negative peaks became positive indicating the intercalation and the conformational change in the DNA. Binding of Alp with DNA increased the thermal stability of DNA by 6 degrees C with respect to the mock treated sample. Gel electrophoresis study of supercoiled pUC 19 DNA showed more compact structure as a result of Alp binding. Transmission electron microscopic observations also confirmed this compactness. Thus, our observations suggest the strong interaction of Alp with DNA, which may raise serious questions about the random uses of Alprazolam.

Analytical study proving alprazolam degradation to its main impurity triazolaminoquinoleine through Maillard reaction.

Anal Bioanal Chem. 2008 Dec 10;
Huidobro AL, Barbas C
Triazolaminoquinoleine is rapidly formed in formulations of alprazolam tablets in presence of excipients, and its generation is speeded up with increasing temperature and humidity. The present paper deals with detailed quantitative and qualitative studies into the nonactive constituents of the formulation in order to determine the excipient (or the mixture) responsible for the degradation. Our studies have demonstrated that reducing carbohydrate excipients play a fundamental role in the generation of triazolaminoquinoleine, with lactose as the main one responsible, through a Maillard reaction. In order to demonstrate the validity of the proposed degradation mechanism, p-nitrobenzaldehyde has been employed as a model of reaction of the nucleophylic attack of amino-opened structure of alprazolam to an aldehyde to generate the first intermediate involved in Maillard reaction, a Schiff base. This model enables the identification of all the intermediates by mass spectrometry and/or nuclear magnetic resonance techniques, with the outcome of this experiment leading to a full understanding of the generation pathway. Calcium carbonate has been proposed as a possible tablet diluent replacing lactose in the pharmaceutical formulation.

Anxiolytic effects of lamotrigine and JZP-4 in the elevated plus maze and in the four plate conflict test.

Eur J Pharmacol. 2008 Nov 17;
Foreman MM, Hanania T, Eller M
JZP-4 is a novel with anticonvulsant, antidepressant and antimania effects in preclinical models. It has some structural similarity to the sodium channel blocker, lamotrigine, but it has both potent sodium and calcium channel blocking activity. In the current studies, JZP-4 was tested in comparison to lamotrigine in the four plate and elevated plus maze tests for anxiolytic activity. In the four plate test, treatment with JZP-4 (30 mg/kg i.p.) produced significant increases in the number of punished crossings. In contrast, lamotrigine produced an inverted U shaped response with a significant increase in punished crossings at 10 mg/kg i.p. but not at 3 or 30 mg/kg i.p. The increased number of punished crossings induced by JZP-4 was similar to that produced by alprazolam (0.3 mg/kg i.p.). In the elevated plus maze test, treatment with either JZP-4 or lamotrigine at 10 mg/kg i.p. produced significant increases in the distance traveled in the open arms. However, only JZP-4 (10 mg/kg i.p.) produced significant increase in the percent of time spend in the open arms. JZP-4, lamotrigine and diazepam did not produce significant changes in the total distance traveled. Indicating that at the doses tested these compounds did not have a sedative effect. These studies have provided preliminary evidence that JZP-4 could have anxiolytic effects in addition to the anticonvulsant, antidepressant and antimania effects reported earlier.

Contribution of alpha1 subunit-containing gamma-aminobutyric acid(A) (GABA (A)) receptors to motor-impairing effects of benzodiazepines in squirrel monkeys.

Psychopharmacology (Berl). 2008 Nov 25;
Licata SC, Platt DM, Cook JM, Van Linn ML, Rowlett JK
RATIONALE: Benzodiazepines (BZs) are effective anxiolytics and hypnotics, but their use is limited by unwanted side effects, such as motor impairment. OBJECTIVES: To assess the contribution of alpha1 subunit-containing gamma-aminobutyric acid(A) (GABA(A)) receptor subtypes to the motor-impairing effects of BZs, the present study evaluated two observable measures of motor coordination (balance on a pole, resistance to hind-limb flexion) engendered by nonselective and selective BZ-site agonists in squirrel monkeys. MATERIALS AND METHODS: Multiple doses of nonselective BZs (triazolam, alprazolam, diazepam, and chlordiazepoxide) and alpha1 subunit-preferring agonists (zolpidem and zaleplon) were administered to adult male squirrel monkeys (N = 4-6), and experimenters rated the monkey's ability to balance on a horizontal pole ("ataxic-like effects"), as well as the degree of resistance to hind-limb flexion ("myorelaxant-like effects"). RESULTS: Administration of all BZ-type drugs resulted in ataxic-like and myorelaxant-like effects. Pretreatment with the alpha1 subunit-preferring antagonist beta-carboline-3-carboxylate-t-butyl ester (betaCCT) attenuated the ataxic-like effects engendered by both types of drugs. However, betaCCT was largely ineffective at blocking the ability of both BZs and non-BZs to induce myorelaxant-like effects. CONCLUSIONS: These experiments demonstrate dose-dependent motor impairment in squirrel monkeys using quantitative behavioral observation techniques. Altogether, these findings suggest a lack of a prominent role for alpha1 subunit-containing receptors in the alteration of hind-limb flexion, a putative measure of myorelaxation, induced by BZ-type drugs in monkeys.

 

This page was last reviewed by Dr Greg Mulhauser, Friday, 4 July 2008.

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