MedPath

Evaluation of the effect of probiotic supplements as adjunctive therapy in improving the symptoms of psychosis, anxiety, insomnia and anorexia due to amphetamine and methamphetamine use

Phase 3
Conditions
substance induced psychosis.
Other psychoactive substance dependence with psychoactive substance-induced psychotic disorder with hallucinations
F19.251
Registration Number
IRCT20220205053945N1
Lead Sponsor
Alborz university of medical sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
50
Inclusion Criteria

Positive amphetamine and methamphetamine test
Diagnosis of amphetamine use disorder based on DSM5 criteria after interview with psychiatrist
Voluntary organization of the individual and his / her guardian to participate in the project
Age: 18 to 60 years old
IQ above 70
Not receiving to receive electroshock in the last two weeks
Do not use other drugs (all opioids, morphine and methadone and marijuana are taken from the patient during the evaluation - testing of urinary toxic acid for amphetamine and methamphetamine)
Lack of other psychiatric disorders such as schizophrenia Bipolar disorder Depression with psychosis

Exclusion Criteria

Prominent neurological or organic disease and cardiovascular disease and history of cardiac surgery or any cardiovascular procedure, clinical and laboratory examinations and review of family history and records
Another diagnosis in Axis I based on DSM-V
IQ less than 70 based on clinician clinical suspicion
Abusing of other substances (except nicotine and caffeine)
Taking oral antipsychotics in the past week or long-acting antipsychotics in the past month
Receiving ECT in the last two weeks
Women of childbearing age will not be accepted without adequate methods of contraception
CHF and liver disease

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Amphetamine and methamphetamine-induced psychosis. Timepoint: At the beginning of this study, 4th and 8th weeks. Method of measurement: Brief Psychiatric Rating Scale.;The Beck Anxiety Inventory (BAI). Timepoint: At the beginning of this study, 4th and 8th weeks. Method of measurement: The Beck Anxiety Inventory (BAI).;Pittsburgh sleep quality index. Timepoint: At the beginning of this study, 4th and 8th weeks. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).
Secondary Outcome Measures
NameTimeMethod
Mild gastrointestinal discomfort. Timepoint: At the beginning of this study, 4th and 8th weeks. Method of measurement: Medical history.
© Copyright 2025. All Rights Reserved by MedPath