Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
Efficacy and Safety of 24 Weeks Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder With Comorbid Opioid Use Disorder - A Multicenter Randomized, Double-blind, Placebo-controlled Study
Parnassia Addiction Research Centre
204 participants
Apr 22, 2026
INTERVENTIONAL
Conditions
Summary
In The Netherlands, each year, about 15 thousand people come into treatment because of problems with cocaine use. There is no approved medication for treatment of cocaine addiction and the psychosocial treatment patients receive is not successful for everyone; many return to treatment several times. There is evidence that agonist ("replacement") medications are effective in treating addiction: methadone for heroin addiction; nicotine replacement for smokers. Dexamphetamine is a stimulant medication registered for treatment of ADHD. It may also be effective as agonist treatment for people with cocaine addiction. It will be investigated whether sustained-release dexamphetamine in people with cocaine addiction, participating in routine methadone maintenance treatment for their comorbid opioid use disorder, (1) reduces cocaine use and (2) improves their health and quality of life.
Eligibility
Inclusion Criteria9
- 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 Criteria13
- 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.
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Interventions
During the first week, patients will be individually titrated to the target dose of 90 mg/day, if tolerated. From the second week onwards, patients are prescribed 3 tablets (30 mg) per day, if tolerated. Titration can be slower but should be finished at the end of week 4. After 4 weeks dosages can no longer be increased, and only be reduced. Patients will visit the treatment centre 2 times per week to take their study medication under supervision of the treatment staff and to receive take-home medication for the days in between study visits. After 24 weeks patients will be randomized to either (double-blind) continuation or discontinuation (placebo) of SR-Dexamphetamine treatment to assess the consequences of discontinuation, during a 6 weeks period.
Dispensed under the same conditions and with similar frequency as the investigational product (see above). After 24 weeks study medication will be discontinued in the placebo group.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05529927