Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder

Inclusion Criteria: * male and female patients between 18 years and over; * actively participating in opioid agonist treatment with oral methadone; * with moderate or severe cocaine use disorder according to DSM-5; * with regular use of cocaine in the previous month (i.e., ≥8 days/month); * with snorting, inhaling or injecting cocaine use as primary route of administration; * express the intention to reduce or stop their cocaine use; * be able and willing to attend the treatment center for 2 days per week; * be able and willing to co-operate with the required study assessments and study procedures; and * have provided written informed consent. Exclusion Criteria: * severe medical (e.g., severe renal or hepatic insufficiency/failure) or severe psychiatric problems (e.g. previous or acute severe psychotic episode, acute suicidality, current bipolar disorder); * cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease, or a prolonged QTc interval (≥500 msec); moderate to severe hypertension (i.e., SBP\>140; DBP\>90); HR\>100, known coronary artery disease (i.e., angina pectoris, acute myocardiac infarction), known cardiomyopathy, CVA; * glaucoma; * Gilles-de-la-Tourette syndrome; * pheochromocytoma; * hyperthyroid status; * pregnancy or continued lactation; * use of monoamine oxidase inhibitor(s) (MAOI): currently or in the past 14 days; * treatment with other prescription psychostimulants that might potentially be effective for stimulant use disorder (i.e., (immediate release) dexamphetamine, lisdexamphetamine, methylphenidate, or modafinil); * anticipated need for inpatient treatment (clinical judgement); * (expected) inability to complete the 30 weeks study (e.g., planned holidays, expected incarceration or hospitalization); * insufficient command of the Dutch language; and * current participation in another addiction treatment study.