DEXAMFETAMINE SULFATE for Amphetamine use disorder | Opioid use disorder

Inclusion criteria

• {"criterion_text":"- Be ≥18 age ≤65 years inclusive, at the time of signing the informed consent.\n- Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n- Dependent on amphetamines according to ICD-10 and an average frequency of use ≥3 days a week during the last 28 days.\n- 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 .\n- 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.\n- The eligibility will be determined by clinical assessment with a medical doctor."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Concomitant treatment with prescribed centrally acting stimulants (e.g. for ADHD).\n- Concurrent participation in other clinical studies when undergoing medication interventions.\n- 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).\n- Challenges related to ability to understand, consent, or willingness to collaborate in follow-up of the study and its protocol.\n- Inability to complete study procedures (e.g. travel plans or likely incarceration).\n- Pregnancy or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- a) The differences in the proportion positive urinary tests on illicit amphetamines and b) mean total self-reported quantity* (mg/day) of amphetamines use between the intervention and control arm during 12-week trial (cumulative data). * Dosage of illicit amphetamines will be converted to prescribed dexamphetamine dosage and added to the prescribed dosage","definition_or_measurement_approach":"Measured as (a) proportion of positive urine tests for illicit amphetamines and (b) mean total self-reported quantity (mg/day) of amphetamines use during the 12-week trial (cumulative). Illicit amphetamine dosage will be converted to prescribed dexamphetamine dosage and added to prescribed dosage for calculation."}

Secondary endpoints

• {"endpoint_text":"- Psychological distress (SCL-10)","definition_or_measurement_approach":"Measured using the SCL-10 questionnaire."}
• {"endpoint_text":"- Psychosis (PANSS: P1, P3, A9)/ LSHS-E","definition_or_measurement_approach":"Measured using PANSS items P1, P3, A9 and LSHS-E."}
• {"endpoint_text":"- ADHD (ASRS)","definition_or_measurement_approach":"Measured using the ASRS instrument."}
• {"endpoint_text":"- Quality of life (EQ-5D-5L)","definition_or_measurement_approach":"Measured using the EQ-5D-5L instrument."}
• {"endpoint_text":"- Executive cognitive performance (TMT B)","definition_or_measurement_approach":"Measured using Trail Making Test B (TMT B)."}
• {"endpoint_text":"- Fatigue (FSS-3)","definition_or_measurement_approach":"Measured using the FSS-3 scale."}
• {"endpoint_text":"- Treatment satisfaction (VAS)","definition_or_measurement_approach":"Measured using a Visual Analogue Scale (VAS) for treatment satisfaction."}
• {"endpoint_text":"- Adherence to OAT (days of drop-out)","definition_or_measurement_approach":"Measured as days of drop-out from opioid agonist treatment (OAT)."}
• {"endpoint_text":"- Days of use of illicit amphetamines (at the end of the 12 weeks)","definition_or_measurement_approach":"Self-reported days of illicit amphetamine use at 12 weeks."}
• {"endpoint_text":"- Days of use and porpotion of other illicit substances and alcohol (self-reports and urinary tests)","definition_or_measurement_approach":"Measured by self-reports and urine tests: days of use and proportion positive for other illicit substances and alcohol."}
• {"endpoint_text":"- Injection-related infections (medical records) and HCV RNA incidence","definition_or_measurement_approach":"Assessed from medical records for injection-related infections and laboratory-confirmed HCV RNA incidence."}
• {"endpoint_text":"- Violence risk (BVC)/(PANSS: P4 and P7)","definition_or_measurement_approach":"Measured using BVC and PANSS items P4 and P7."}
• {"endpoint_text":"- Criminality (criminal actions)","definition_or_measurement_approach":"Measured as recorded criminal actions/events."}
• {"endpoint_text":"- Sleep (ISI)","definition_or_measurement_approach":"Measured using the Insomnia Severity Index (ISI)."}
• {"endpoint_text":"- Private economy (total and health-related)","definition_or_measurement_approach":"Measured as total and health-related private economic outcomes (questionnaires)."}
• {"endpoint_text":"- Craving and withdrawals to amphetamines","definition_or_measurement_approach":"Measured using validated craving and withdrawal assessments (as per protocol questionnaires)."}
• {"endpoint_text":"- Sucidality risk at the end of 12-week trial.","definition_or_measurement_approach":"Assessed for suicidality risk at end of 12-week trial using clinical assessment tools (as per protocol)."}

Norway

Earliest CTIS Part Ii Submission Date

26-02-2024

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

535

Number Of Sites

4

Number Of Participants

226

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway