Comparison of the effect of Sophora alopecuroides var. alopecuroides and placebo on the clinical opiate withdrawal scale in heroin addicts: a clinical trial

Comparison of the effectiveness of Sophora alopecuroides var. alopecuroides and placebo in the treatment of heroin withdrawal symptoms

Phase 3 clinical trial having parallel placebo group, triple-blind, randomized by blocking using computer generated random numbers table and sequentially numbered containers each representing a block consisting of ten patients, single-center with 100 heroin addict patients is performed.

The trial setting: Izad Mehr Setayesh addiction treatment camp. Protocol: fifty patients take three 400 mg capsules of the plant's seed extract and 50 patients take 3 placebo capsules once daily for 8 days. Before intervention and 8 days after intervention, the groups' scores of clinical opiate withdrawal scale and blood levels of aspartate aminotransferase, alanine aminotransferase and creatinine are compared. Blinding: letters A or B are labeled on drug or placebo containers. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are not aware of the type of group they are in.

Inclusion criteria: patients who according to the DSM-V criteria are dependent on heroin for at least 1 year. Exclusion criteria: individuals who besides heroin abuse other substances except for tobacco.

Fifty patients use three 400 mg capsules of the plant's seed extract and 50 patients use 3 placebo capsules once orally every 24 hours for 8 days.

Primary outcome variable: score of clinical opiate withdrawal scale. Secondary outcome variables: blood levels of aspartate aminotransferase, alanine aminotransferase and creatinine.

Block randomization using computer generated random numbers and sequentially numbered containers each representing a block of ten patients is used for treatment assignment.

Letters A or B are labeled on herbal drug or placebo containers. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are aware that they are either in the drug or in the placebo group, but they are not aware of the type of group they are in.

All collected deidentified IPD are to be shared.

Access period starting 6 months after publication for 1 year.

Researchers working in university and scientific and industrial institutes.

Only statistical analyses mentioned in the article resulting from the study for personal knowledge are permitted. Written request for access to data and documents and its aim must be certified by the highest ranking official of the work place of the requester.

Dr. Saeed Kianbakht with the address ACECR Institute of Medicinal plants, P.O. Box: 31375-369, Iran.

Written request should be sent to the address Dr. Saeed Kianbakht, ACECR Institute of Medicinal Plants, P.O. Box: 31375-369, Iran. The documents or data file will be sent to the requester by email.