Dextroamphetamine Substitution for Amphetamines Dependence: A Randomized Controlled Trial
- Conditions
- Comorbid dependencies to amphetamines and opioidsTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-508291-11-00
- Lead Sponsor
- Helse Bergen HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 222
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 with a minimum duration of 3 years and an average frequency of use =4 days a week during the last 28 days, and have concurrent opioid dependence according to ICD-10 receiving a stabilized dose with OAT medication 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.
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 six 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method