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IRCT20220205053945N1 IRCT 2022-03-17 Alborz university of medical sciences 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 2022-05-20 anticipated 50 Complete https://irct.ir/trial/61762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, people with amphetamine and methamphetamine use disorders are identified based on a positive amphetamine and methamphetamine test and then a full interview by a psychiatrist with DSM5 characteristics. Persons that are included in the study are divided into two groups of intervention and control by simple randomization methods, in which agreed from the beginning that the intervention group will be given individual numbers and the control group will be given even numbers. Then, according to the number of study sample volumes, from the table of random numbers, relevant numbers are extracted. Each number is written on a card and placed in an envelope. The envelopes are sealed and the patient number is written on each envelope. Patient No. 1, Patient No. 2 will be given Envelope No. 2 and so on. In the same way, this work will continue until the end of the study sample volume. To maintain randomization, the person who prepares the envelopes is different from the person who registers the patients and provides the envelopes to the patients, Blinding description: The study is double-blind and the researcher and the patient will not know the type of drug and the drugs are selected by another person in the form of capsules completely similar to the drug-placebo and the patient is given a completely random one between the drug and the placebo with code one and two. 3 substance induced psychosis. 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 capsules for 8 weeks. Yes - There is a plan to make this available What will be shared: We are going to share required data When: available on March 2022 To whom: Public article Conditions: Unconditional Where to obtain: Publisher journal or please sent massage to ah.hajialigol@gmail.com How to obtain: sent massage to ah.hajialigol@gmail.com Comments:
public Atefe Zandifar
Imam Ali hospital, beginning of Kaj blvd., Karaj
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3250 0123 emamali@abzums.ac.ir Alborz university of medical sciences scientific Atefe Zandifar
Imam Ali hospital, beginning of Kaj blvd., Karaj
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3250 0123 emamali@abzums.ac.ir Alborz university of medical sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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 F19.251 Other psychoactive substance dependence with psychoactive substance-induced psychotic disorder with hallucinations Treatment - Drugs Placebo Intervention group: lactobacillus acidophilus capsule 10 exponent 8 unit daily for 8 weeks Control group: Starch placebo tablets exactly the same with probiotic capsules for 8 weeks 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). Mild gastrointestinal discomfort. Timepoint: At the beginning of this study, 4th and 8th weeks. Method of measurement: Medical history. Alborz university of medical sciences Approved 2022-02-01 Ethics committee of Alborz University of Medical Sciences Ethics Committee Office, 2nd floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Gol-shahr Karaj Alborz Iran (Islamic Republic of)