Opioid Withdrawal
Conditions
Brief summary
It is a single blind randomized symptom triggered study to assess efficacy and safety of pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs. clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.
Detailed description
Study design: Single-blind randomized symptom-regulated protocol with an active control. Eighty patients admitted to an inpatient addiction treatment program will be randomly assigned to two groups. The first group (N=40) receives up to 600 mg a day of Pregabalin for six days along with symptomatic therapy that is divided into basic treatment that is given to all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine). The second group (N= 40) receives up to 600 micrograms of Clonidine a day as the main treatment along with the same basic and symptomatic regimen. Opiate withdrawal severity, craving, sleep disturbance, anxiety and depression, as well as general clinical impressions and side effects are assessed daily by psychiatrists who are blind to patients' group assignment using internationally validated quantitative psychometric instruments.
Interventions
DRUGPregabalin
Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).
DRUGClonidine
Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
DRUGDoxylamin
DRUGKetorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
Sponsors
St. Petersburg Bekhterev Research Psychoneurological Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Opioid Use Disorders; Opioid Withdrawal Syndrome
Exclusion criteria
* Severe psychiatric and somatic disorders, other Substance Use Disorders (except tobacco)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients completed detoxification | 7 days | Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of opiod withdrawal | 7 days | Compares changes of severity of opioid withdrawal syndrome in two arms |
| Amount of Ketorolac administered | 7 days | Compares amount of Ketorolac administered under the symptom triggered protocol (per patient's request of physician's judgement) in two arms. |
| Number and severity of adverse events | 7 days | Compares number and severity of adverse events in two treatment arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Craving for opiates | 7 days | Craving for opiates will be measured with the visual analog scale. Compares craving for opiates in two treatment arms during detoxification. |
Countries
Russia
Outcome results
None listed