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

RecruitingPhase 2Ages 18 Years - anyAllParnassia Addiction Research Centre
NCT05529927 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sustained-release Dexamphetamine
  • Placebo
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Where

1 site
Brijder Den Haag
The Hague, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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