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Dextroamphetamine Substitution for Amphetamines Dependence: A Randomized Controlled Trial
EU CTIS ID: 2023-508291-11-00
What this study is testing
a) To assess the impact of 12 weeks daily prescribed oral dextroamphetamine versus placebo on illicit amphetamines use and b) the total amount of amphetamines use in amphetamine-dependent patients undergoing opioid agonist treatment.
- Therapeutic exploratory (Phase II)
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
- Be ≥18 age ≤65 years inclusive, at the time of signing the informed consent.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Dependent on amphetamines according to ICD-10 and an average frequency of use ≥3 days a week during the last 28 days.
- If female and child-bearing potential, contraceptive should be used consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Non-pregnancy should be confirmed by a test if indicated .
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- The eligibility will be determined by clinical assessment with a medical doctor.
You likely can't join if
- Contraindications pointed in the IPB (concomitant use of MAO-inhibitors or less than 14 days after the last dose of these drugs; symptomatic cardiovascular diseases (QTc>500 ms, persistent moderate to severe hypertension i.e. blood pressure [BP]≥140/90 mm Hg not controlled by a single anti-hypertensive agent (see Section 8.3.2.), prior myocardial infarction or stroke, advanced atherosclerosis); glaucoma; known hyperthyroidism or biochemical profiles from blood samples indicating of that; moderate or severe renal failure (i.e. GFR<100 ml/min/1,73 m²); agitation conditions.
- Concomitant treatment with prescribed centrally acting stimulants (e.g. for ADHD).
- Concurrent participation in other clinical studies when undergoing medication interventions.
- Diagnostic assessments indicative for following conditions; ICD-10 diagnosis of multiple substances overdoses during the past three months (F10.0-19.0) based on medical records; ICD-10 diagnosis of a psychosis spectrum disorder (F20-29), or substance induced psychosis (F10.5-F19.5), or affective psychosis (F30, F31, F32.3) based on medical records if these conditions have been under treatment the last six months, or a score of ≥4 on the following psychosis symptoms items on the PANSS: P1 – delusions; P3 – hallucinatory behavior; A9 – unusual thought content (based on the interview conducted at the time of screening); seizure; recent high risk of agitation and violent behavior e.g. dissocial personality disorders or affective disorders; severe cognitive impairment (based on clinical assessments or using HASI if indicated); suicidality (based on clinical assessments).
- Challenges related to ability to understand, consent, or willingness to collaborate in follow-up of the study and its protocol.
- Inability to complete study procedures (e.g. travel plans or likely incarceration).
See the full eligibility criteria
Who can join
- Be ≥18 age ≤65 years inclusive, at the time of signing the informed consent.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Dependent on amphetamines according to ICD-10 and an average frequency of use ≥3 days a week during the last 28 days.
- If female and child-bearing potential, contraceptive should be used consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Non-pregnancy should be confirmed by a test if indicated .
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- The eligibility will be determined by clinical assessment with a medical doctor.
What rules you out
- Contraindications pointed in the IPB (concomitant use of MAO-inhibitors or less than 14 days after the last dose of these drugs; symptomatic cardiovascular diseases (QTc>500 ms, persistent moderate to severe hypertension i.e. blood pressure [BP]≥140/90 mm Hg not controlled by a single anti-hypertensive agent (see Section 8.3.2.), prior myocardial infarction or stroke, advanced atherosclerosis); glaucoma; known hyperthyroidism or biochemical profiles from blood samples indicating of that; moderate or severe renal failure (i.e. GFR<100 ml/min/1,73 m²); agitation conditions.
- Concomitant treatment with prescribed centrally acting stimulants (e.g. for ADHD).
- Concurrent participation in other clinical studies when undergoing medication interventions.
- Diagnostic assessments indicative for following conditions; ICD-10 diagnosis of multiple substances overdoses during the past three months (F10.0-19.0) based on medical records; ICD-10 diagnosis of a psychosis spectrum disorder (F20-29), or substance induced psychosis (F10.5-F19.5), or affective psychosis (F30, F31, F32.3) based on medical records if these conditions have been under treatment the last six months, or a score of ≥4 on the following psychosis symptoms items on the PANSS: P1 – delusions; P3 – hallucinatory behavior; A9 – unusual thought content (based on the interview conducted at the time of screening); seizure; recent high risk of agitation and violent behavior e.g. dissocial personality disorders or affective disorders; severe cognitive impairment (based on clinical assessments or using HASI if indicated); suicidality (based on clinical assessments).
- Challenges related to ability to understand, consent, or willingness to collaborate in follow-up of the study and its protocol.
- Inability to complete study procedures (e.g. travel plans or likely incarceration).
- Pregnancy or breastfeeding.
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. 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.