Pregabalin for Opiate Withdrawal Syndrome
Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 6, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 7, 2020
April 1, 2020
5.9 years
January 6, 2017
April 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients completed detoxification
Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms.
7 days
Secondary Outcomes (3)
Severity of opiod withdrawal
7 days
Amount of Ketorolac administered
7 days
Number and severity of adverse events
7 days
Other Outcomes (1)
Craving for opiates
7 days
Study Arms (2)
Pregabalin
EXPERIMENTALThis group (N= 40) receives up to 600 mg a day of Pregabalin for six-seven 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).
Clonidine
ACTIVE COMPARATORThis group (N= 40) receives up to 600 micrograms of Clonidine a day for six-seven 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)..
Interventions
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 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
Eligibility Criteria
You may qualify if:
- Opioid Use Disorders; Opioid Withdrawal Syndrome
You may not qualify if:
- Severe psychiatric and somatic disorders, other Substance Use Disorders (except tobacco)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St.-Petersburg Bekhterev Reserach Psychoneurological Institute
Saint Petersburg, 192019, Russia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2017
First Posted
January 11, 2017
Study Start
January 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 7, 2020
Record last verified: 2020-04