NCT05529927 Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
| NCT ID | NCT05529927 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Parnassia Addiction Research Centre |
| Condition | Cocaine Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 204 participants in total. It began in 2026-04-22 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Vincent Hendriks, PhD.
PRINCIPAL INVESTIGATOR
Parnassia Addiction Research Centre
Frequently Asked Questions
Who can join the NCT05529927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cocaine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05529927 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05529927 currently recruiting?
Yes, NCT05529927 is actively recruiting participants. Contact the research team at vincent.hendriks@brijder.nl for enrollment information.
Where is the NCT05529927 trial being conducted?
This trial is being conducted at The Hague, Netherlands.
Who is sponsoring the NCT05529927 clinical trial?
NCT05529927 is sponsored by Parnassia Addiction Research Centre. The principal investigator is Vincent Hendriks, PhD. at Parnassia Addiction Research Centre. The trial plans to enroll 204 participants.