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Impact of dextroamphetamine substitution on the use of illicit amphetamines in adults with comorbid dependencies to amphetamines and opioids undergoing opioid agonist treatment: A multi-center double blind randomized controlled study (ATLAS4Dependence)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508291-11-00
Enrollment
226
Registered
2024-03-22
Start date
2024-09-18
Completion date
Unknown
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbid dependencies to amphetamines and opioids

Brief summary

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

Detailed description

Psychological distress (SCL-10), Psychosis (PANSS: P1, P3, A9)/ LSHS-E, ADHD (ASRS), Quality of life (EQ-5D-5L), Executive cognitive performance (TMT B), Fatigue (FSS-3), Treatment satisfaction (VAS), Adherence to OAT (days of drop-out), Days of use of illicit amphetamines (at the end of the 12 weeks), Days of use and porpotion of other illicit substances and alcohol (self-reports and urinary tests), Injection-related infections (medical records) and HCV RNA incidence, Violence risk (BVC)/(PANSS: P4 and P7), Criminality (criminal actions), Sleep (ISI), Private economy (total and health-related), Craving and withdrawals to amphetamines, Sucidality risk at the end of 12-week trial.

Interventions

DRUGPlacebo matching active treatment

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Psychological distress (SCL-10), Psychosis (PANSS: P1, P3, A9)/ LSHS-E, ADHD (ASRS), Quality of life (EQ-5D-5L), Executive cognitive performance (TMT B), Fatigue (FSS-3), Treatment satisfaction (VAS), Adherence to OAT (days of drop-out), Days of use of illicit amphetamines (at the end of the 12 weeks), Days of use and porpotion of other illicit substances and alcohol (self-reports and urinary tests), Injection-related infections (medical records) and HCV RNA incidence, Violence risk (BVC)/(PANSS: P4 and P7), Criminality (criminal actions), Sleep (ISI), Private economy (total and health-related), Craving and withdrawals to amphetamines, Sucidality risk at the end of 12-week trial.

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026