Opium use disorder. Mental and behavioral disorders due to use of opioids_dependence syndrome
Conditions
Interventions
Intervention 1: patients receiving 15 mg or less than 15 mg of methadone, 5 mg haloperidol will be administered each day
patients receiving 15 to 30 mg of methadone, haloperidol will be administered 10 mg daily
patients receiving 30 to 45 mg of methadone, will be administered 15 mg haloperidol daily
and patients receiving more than 45 mg methadone, will be administered 20 mg haloperidol daily. Haloperidol will be continued for one week after discontinuation of methadone and thereafter it will be
patients receiving 15 to 30 mg of methadone, placebo will be administered 10 mg daily
patients receiving 30 to 45 mg of methadone, will be administered 15 mg placebo daily
and patients receiving more than 45 mg methadone, will be administered 20 mg placebo daily. Placebo will be continued for one week after discontinuation of methadone and thereafter it will be reduced
Placebo
patients receiving 15 mg or less than 15 mg of methadone, 5 mg haloperidol will be administered each day
patients receiving 15 mg or less than 15 mg of methadone, 5 mg placebo will be administered each day
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:A reliable history of opioids consumptions until the onset of the study; DSM-5 criteria for opioid use disorder; Positive urine rapid test of opioids Exclusion criteria:Enzyme inducers medication usage or other medical treatments;History of Sensitivity to haloperidol; Poly substance use (Cannabinoids ,Alcohol , barbiturates , benzodiazepines, analgesics) and use of antidepressants , other antipsychotics , beta blockers , alpha 2 agonists, inhibitors of CYP 3A4 , and CYP2D6 in the last month before study (except nicotine); Major depressive disorder, Bipolar mood disorder, severe anxiety disorders and Psychosis; Severe medical illnesses such as epilepsy, hepatitis, tuberculosis, AIDS, liver dysfunction, renal dysfunction; Pregnancy and Lactation; Electroconvulsive therapy in the last 6 months; Suicidal ideation or suicidal attempt at the beginning of the study or within the last 6 months; Mental retardation; Neurological disorder such as dementia, uncontrolled epilepsy and history of head trauma ; Past history of neuroleptic malignant syndrome.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute opioid withdrawal symptoms. Timepoint: every other day. Method of measurement: Objective opioid withdrawal scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Extrapyramidal symptoms, serum prolactin level. Timepoint: Extrapyramidal symptoms will be assessed by everyday clinical assessment, prolactine; and serum prolactin level, before & after the end of the study. Method of measurement: History & Physical Exam & labratory test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mehran Zarghami
Mazandaran University of Medical Sciences
Outcome results
None listed