RecruitingPhase 2

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

Netherlands204 participantsStarted 2026-04-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 po…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary outcome measure for the primary study objective (to evaluate the efficacy of 24 weeks SR-dexamphetamine, compared with 24 weeks placebo): the number of days cocaine abstinence.

Timeframe: Final 4 weeks of treatment (first study phase; i.e., week 21-24)

Trial details

NCT IDNCT05529927

SponsorParnassia Addiction Research Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Vincent Hendriks, PhD.

+31651154583 vincent.hendriks@brijder.nl

View on ClinicalTrials.gov More Cocaine Use Disorder trials