Therapeutic compositions and methods

A method of treating or preventing nicotine, methamphetamine, and/or alcohol addiction, nicotine, methamphetamine, and/or alcohol addiction induced anxiety, and/or nicotine, methamphetamine, and/or alcohol withdrawal symptoms in a patient in need thereof, comprising:

• selecting a patient in need of treating or preventing a condition selected from the group consisting of nicotine, methamphetamine, and/or alcohol addiction;
• nicotine, methamphetamine, and/or alcohol addiction induced anxiety;
• and nicotine, methamphetamine, and/or alcohol withdrawal symptoms;
• administering a composition comprising:
• i) ORG 34517, or pharmaceutically acceptable salts thereof;
• ii) at least one additional therapeutic agent(s) selected from the group consisting of anxiolytics, antidepressants, neuroleptics, or other psychotropic medications and combinations thereof;
• and
• iii) at least one pharmaceutically acceptable carrier,
• wherein the ORG 34517 and at least one additional therapeutic agents are each present in an amount which, in combination, is a therapeutically effective amount for treating or preventing the condition.

A method of treating or preventing nicotine, methamphetamine, and/or alcohol addiction, nicotine, methamphetamine, and/or alcohol addiction induced anxiety, and/or nicotine, methamphetamine, and/or alcohol withdrawal symptoms in a patient, comprising the steps of:

• a) obtaining a test sample from the patient using a test sample collection unit;
• b) combining said test sample with a buffering system to form a mixture in a reaction unit;
• c) measuring a parameter of the mixture to determine a blank measurement;
• d) combining said test sample and buffer mixture with a labeled ligand which binds cortisol in the reaction unit to produce an assay solution;
• or combining said test sample and buffer mixture and delivering it to a carrier containing a labeled ligand which binds cortisol in the reaction unit to produce an assay immobilized complex;
• e) measuring a parameter of said assay solution or complex;
• f) comparing the measurement of the assay solution relative to the blank measurement;
• g) determining the patient's circulating cortisol levels based on the change of the measurement;
• h) comparing the measured cortisol levels to a predetermined reference range cortisol levels, wherein when the level of cortisol is elevated relative to the predetermined reference range, then the patient has elevated cortisol, and thus is suitable for GCR (glucocorticoid receptor) antagonist therapy;
• and
• i) when the patient is suitable for GCR antagonist therapy, administering at least ORG 34517,
• thereby treating or preventing nicotine, methamphetamine, and/or alcohol addiction, nicotine, methamphetamine, and/or alcohol addiction induced anxiety, and/or nicotine methamphetamine, and/or alcohol withdrawal symptoms in the patient.