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
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
Design
A double-blind randomized placebo-controlled clinical trial at Imam Hossein Hospital with a parallel group design of 50 patients, enrolled between April 2022 , and followed for 8 weeks, simple random sampling.
Settings and conduct
A double-blind randomized placebo-controlled clinical trial at Imam Hossein Hospital with a parallel group design of 50 patients. Researcher and patients are blinded. Similar capsules of the drug-placebo are given randomly with codes one and two.
Participants/Inclusion and exclusion criteria
Inclusion criteria: positive amphetamine and methamphetamine test; diagnosis of amphetamine use disorder based on DSM5 criteria after interview; voluntary organization of the individual and his / her guardian to participate in the project; age: 18 to 60 years old old; IQ above 70; not receiving to receive electroshock in the last two weeks; do not use other drugs; lack of other psychiatric disorders.
Exclusion criteria: prominent neurological or organic disease and cardiovascular disease and history of cardiac surgery or any cardiovascular procedure, clinical and laboratory examinations and family history; 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.
Intervention groups
intervention : lactobacillus acidophilus capsule 10 exponent 8 unit daily 8 weeks
Control : Starch placebo tablets exactly the same with probiotic capsules 8 weeks
Main outcome variables
Amphetamine-induced psychosis; anxiety; insomnia and loss of appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220205053945N1
Registration date:2022-03-17, 1400/12/26
Registration timing:prospective
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
Maryam Rashidian
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5564 8814
Email address
maryamrashidian1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics Committee Office, 2nd floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Gol-shahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.ABZUMS.REC.1400.302
Health conditions studied
1
Description of health condition studied
substance induced psychosis
ICD-10 code
F19.251
ICD-10 code description
Other psychoactive substance dependence with psychoactive substance-induced psychotic disorder with hallucinations
Primary outcomes
1
Description
Amphetamine and methamphetamine-induced psychosis
Timepoint
At the beginning of this study, 4th and 8th weeks
Method of measurement
Brief Psychiatric Rating Scale
2
Description
The Beck Anxiety Inventory (BAI)
Timepoint
At the beginning of this study, 4th and 8th weeks
Method of measurement
The Beck Anxiety Inventory (BAI)
3
Description
Pittsburgh sleep quality index
Timepoint
At the beginning of this study, 4th and 8th weeks
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
Description
Mild gastrointestinal discomfort
Timepoint
At the beginning of this study, 4th and 8th weeks
Method of measurement
Medical history
Intervention groups
1
Description
Intervention group: lactobacillus acidophilus capsule 10 exponent 8 unit daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Starch placebo tablets exactly the same with probiotic capsules for 8 weeks