Method of controlling depression in subjects treated for opioid dependence

Inventors

Sumner, Michael John

Assignees

Orexo AB

Abstract

The present disclosure is directed to a method of combatting opioid dependence in a subject experiencing a depressive episode. The method comprises treating the subject with an opioid agonist whilst managing their depression or depressive disorder using a step-wise interactive process, particularly where the process involves virtual cognitive behavioral therapy comprising a program for self-treatment. The self-treatment program could be embodied as a mobile medical application.

Core Innovation

A method is provided for treating opioid dependence in a patient with depression by administering a sublingual dose of buprenorphine and naloxone in a treatment regimen effective to manage withdrawal symptoms and cravings. In conjunction with the sublingual dose, the patient engages in a self-directed digital, interactive cognitive behavioral therapy program provided via a software application that treats the depression, thereby increasing adherence to the treatment regimen.

The software application comprises a plurality of modules providing therapeutic content implementing a plurality of psychotherapeutic approaches. The software application receives feedback from the patient and, based on the feedback, adjusts at least one of an order in which the plurality of modules are presented to the patient or the digital therapeutic content provided by the plurality of modules.

In related aspects, the depression is treated by decreasing at least one of anxiety, panic, traumatic intrusions, or suicidal intent exhibited by the patient. Treating the depression in conjunction with the buprenorphine and naloxone regimen causes the patient to decrease concomitant use of a benzodiazepine and decreases a risk of an adverse reaction or drug interaction between the benzodiazepine and the sublingual dose, improving a safety profile of the sublingual dose of buprenorphine and naloxone.

Claims Coverage

The partial content includes three independent claims. Across these claims, the inventive features cover combined sublingual buprenorphine and naloxone with a self-directed digital interactive CBT, a module-based digital CBT system that receives patient feedback and adjusts module order and/or delivered content, and depression treatment effects with benzodiazepine/drug-interaction risk reduction.

The independent claims consistently require combined opioid dependence treatment using sublingual buprenorphine and naloxone with a digital, interactive or fully automated online CBT for depression. They further require a plurality of therapeutic modules implementing multiple psychotherapeutic approaches with patient feedback or input used to adjust module presentation order and/or delivered therapeutic content, and include benzodiazepine use reduction and drug-interaction risk reduction in the partial content.

Stated Advantages

Documented Applications