Mazindol treatment for heroin dependence and substance use disorder

1. A method of treatment of substance abuse disorder comprising administering mazindol or composition comprising mazindol to a subject, wherein the substance is an opioid and mazindol is administered daily at a daily dosage range of between 3 mg and 16 mg.

2. The method according to claim 1 , wherein the substance is heroin.

3. The method according to claim 1 , wherein mazindol or the composition comprising mazindol is administered via oral administration, preferably in the form of a tablet.

4. The method according to claim 3 , wherein mazindol or the composition comprising mazindol is administered in the form of a tablet and the tablet comprises 1 to 6 mg of mazindol.

5. The method according to claim 1 , wherein mazindol is in the form of a multilayer matrix-type tablet comprising:

at least one immediate-release (IR) layer comprising mazindol and at least one diluent,

at least one sustained-release layer (SR) comprising mazindol and at least one sustained-release, pH independent and water-insoluble polymer.

6. The method according to claim 5 , wherein the ratio in weight between the IR layers and the SR layers is between 40:60 and 80:20.

7. The method according to claim 5 , wherein the tablet has a dissolution of between 60% and 80% at 1 hour, and of between 70% and 90% at 2 hours.

8. The method of claim 5 , wherein the weight ratio ranges from 50:50 to 70:30.

9. The method of claim 5 , wherein the weight ratio is 50:50.