Study of ifenprodil in methamphetamine dependence

Not Applicable

• Conditions: Stimulant Use Disorder (amphetamine-type substance)

• Registration Number: JPRN-jRCTs031180080
• Lead Sponsor: Matsumoto Toshihiko

Brief Summary

We examined the safety and appropriate outcomes of ifenprodil for the treatment of patients with methamphetamine dependence. We found that there were no safety issues and a 120 mg/day ifenprodil group improved their drug use status and sub-scale scores on the relapse risk scale compared with placebo and 60 mg/day ifenprodil groups. These results demonstrate the potential that appropriate outcomes can be achieved with high dose ifenprodil treatment for methamphetamine dependence.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-15
• Study Completion: 2019-09-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence or absence of methamphetamine use during the 84-day administration period of ifenprodil or placebo.

Secondary Outcome Measures

Name	Time	Method
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). <br>2) Positive urine for methamphetamine (positive/negative, number of times, ratio) during the 84-day administration period. <br>3) Relapse risk (the Stimulant Relapse Risk Scale). <br>4) Drug craving (Numerical Rating Scale, 11-point scale). <br>5) Above outcomes assessed for 6 months (including 3 months after the medication).