Sustained-release dexamphetamine for cocaine use disorder in people also on methadone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial enrolls adults with moderate to severe cocaine use disorder who are on oral methadone maintenance. Participants are assigned to sustained-release dexamphetamine or placebo for 24 weeks, followed by a 6-week randomized treatment-discontinuation phase to observe consequences of stopping treatment. The goal is to see if the medication lowers cocaine use and improves health and quality of life, while monitoring safety. The study uses a titration strategy with 30 mg dexamphetamine sulfate tablets given in sustained-release form. Investigators will compare outcomes between groups and assess adverse events and adherence across multiple Dutch centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brijder Den Haag
  The Hague, Netherlands Recruiting

Study contacts

• Principal investigator: Vincent Hendriks, PhD. — Parnassia Addiction Research Centre
• Study coordinator: Vincent Hendriks, PhD.
• Email: vincent.hendriks@brijder.nl
• Phone: +31651154583

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.