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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

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. A double-blind randomized placebo-controlled clinical trial at Imam Hossein Hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220205053945N1
Enrollment
50
Registered
2022-03-17
Start date
2022-05-20
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

substance induced psychosis. Other psychoactive substance dependence with psychoactive substance-induced psychotic disorder with hallucinations

Interventions

Intervention 1: Intervention group: lactobacillus acidophilus capsule 10 exponent 8 unit daily for 8 weeks. Intervention 2: Control group: Starch placebo tablets exactly the same with probiotic capsul

Sponsors

Alborz university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Mild gastrointestinal discomfort. Timepoint: At the beginning of this study, 4th and 8th weeks. Method of measurement: Medical history.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtefe Zandifar

Alborz university of medical sciences

emamali@abzums.ac.ir+98 26 3250 0123

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026