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REDUCE: Research on sustained-release dexamphetamine treatment for cocaine use disorder
EU CTIS ID: 2023-505556-21-00
What this study is testing
To evaluate the efficacy of 24 weeks SR-dexamphetamine (individually titrated to a maximum dosage of 90 mg/day, as tolerated), compared with 24 weeks placebo, in patients with moderate/severe cocaine use disorder, in routine opioid agonist treatment with oral methadone for their comorbid opioid dependence in terms of days of cocaine abstinence and overall health status.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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
You likely can't join if
- severe medical (e.g., severe renal or hepatic insufficiency/failure) or severe psychiatric problems (e.g. severe previous or acute psychotic episode, acute suicidality, current bipolar disorder)
- 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
- current participation in another addiction treatment study
- cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease; moderate to severe hypertension (i.e., SBP>140; DBP>90); HR>100, known coronary artery disease (i.e., angina pectoris, acute myocardial infarction), known cardiomyopathy, CVA
See the full eligibility criteria
- 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
- 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
- have provided written informed consent
- severe medical (e.g., severe renal or hepatic insufficiency/failure) or severe psychiatric problems (e.g. severe previous or acute psychotic episode, acute suicidality, current bipolar disorder)
- 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
- current participation in another addiction treatment study
- cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease; moderate to severe hypertension (i.e., SBP>140; DBP>90); HR>100, known coronary artery disease (i.e., angina pectoris, acute myocardial infarction), known cardiomyopathy, CVA
- glaucoma
- Gilles-de-la-Tourettesyndrome
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.