Pregabalin for Opiate Withdrawal Syndrome

Opioid Withdrawal Clinical Trial

Official title:

Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017430
• Other study ID #: BRPI-PGBL-OW01
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: St. Petersburg Bekhterev Research Psychoneurological Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion Criteria:

• Severe psychiatric and somatic disorders, other Substance Use Disorders (except tobacco)

Related Conditions & MeSH terms

• Opioid Withdrawal
• Substance Withdrawal Syndrome

Intervention

Drug:
• Pregabalin
Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).
• Clonidine
Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
• Doxylamin

• Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)

Locations

Country	Name	City	State
Russian Federation	St.-Petersburg Bekhterev Reserach Psychoneurological Institute	St.-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg Bekhterev Research Psychoneurological Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Craving for opiates	Craving for opiates will be measured with the visual analog scale. Compares craving for opiates in two treatment arms during detoxification.	7 days
Primary	Number of patients completed detoxification	Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms.	7 days
Secondary	Severity of opiod withdrawal	Compares changes of severity of opioid withdrawal syndrome in two arms	7 days
Secondary	Amount of Ketorolac administered	Compares amount of Ketorolac administered under the symptom triggered protocol (per patient's request of physician's judgement) in two arms.	7 days
Secondary	Number and severity of adverse events	Compares number and severity of adverse events in two treatment arms	7 days