Study of ifenprodil in methamphetamine dependence

JRCT ID: jRCTs031180080

Registered date:15/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stimulant Use Disorder (amphetamine-type substance)
• Date of first enrollment: 18/01/2018
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Ifenprodil (84 days)

Outcome(s)

• Primary Outcome: The presence or absence of methamphetamine use during the 84-day administration period of ifenprodil or placebo.

Secondary Outcome

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).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Matsumoto Toshihiko
• Secondary Sponsor: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000030849