Study of ifenprodil effects on patients with methamphetamine dependence and development of fMRI biomarkers for methamphetamine dependence

Not Applicable

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

• Registration Number: JPRN-UMIN000030849
• Lead Sponsor: ational Center of Neurology and Psychiatry, National Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Study Completion: 2019-09-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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). 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).