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Tests treatment safety and results for Cocaine Use Disorder
Official title Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
ClinicalTrials.gov ID: NCT05529927
What this study is testing
What is Sustained-release Dexamphetamine?
Sustained-release Dexamphetamine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for cocaine use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- severe medical (e.g., severe renal or hepatic insufficiency/failure) or severe psychiatric problems (e.g. previous or acute severe psychotic episode...
- cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease, or a prolonged...
- glaucoma;
- Gilles-de-la-Tourette syndrome;
- pheochromocytoma;
- hyperthyroid status;
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- The Hague, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Hague, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.