Stimulant Use Disorder (amphetamine-type substance)
Conditions
Interventions
Ifenprodil (120 mg/day, 84 days)
Ifenprodil (60 mg/day, 84 days)
Placebo (84 days)
Sponsors
National Center of Neurology and Psychiatry, National Center Hospital
Tokyo Metropolitan Institute of Medical Science, National Center of Neurology and Psychiatry (Integrative Brain Imaging Center), Kyoto University, Advanced Telecommunications Research Institute International
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatients who were diagnosed with methamphetamine use disorder assessed by DSM-5 (including first visit and return visit). 2) Those who used methamphetamine in the past year. 3) Those who are age 20 years old <= at obtaining of informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with severe physical diseases. 2) Patients with high suicide risk. 3) Patients with severe symptoms of substance-induced psychotic disorder. 4) Patients with impaired cognitive function. 5) Patients who do not wish to be notified of the fMRI examination results. 6) Patients judged ineligible to participate in the study by the attending psychiatrist. 7) Patients taking paroxetine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence or absence of methamphetamine use during the 84-day administration period of ifenprodil or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The days and percentage of days abstinent from methamphetamine during the 84-day administration period (assessed by self-reports using the Timeline Follow-back method). The days and percentage of days of methamphetamine use during the 84-day administration period (assessed by self-reports using the Timeline Follow-back method). 2) Positive urine for methamphetamine (positive/negative, number of times, ratio) during the 84-day administration period. 3) Relapse risk (the Stimulant Relapse Risk Scale). 4) Drug craving (Numerical Rating Scale, 11-point scale). 5) Above outcomes assessed for 6 months (including 3 months after the medication). | — |
Countries
Japan
Contacts
Public ContactKazutaka Ikeda
Tokyo Metropolitan Institute of Medical Science Department of Psychiatry and Behavioral Sciences, Addictive Substance Project
Outcome results
None listed