Pregabalin for Opiate Withdrawal Syndrome

Overview

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.

Full Title of Study: “Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2019

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

  • 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).
  • Drug: 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)
  • Drug: Doxylamin
  • Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)

Arms, Groups and Cohorts

  • Experimental: Pregabalin
    • This 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).
  • Active Comparator: Clonidine
    • This 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)..

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients completed detoxification
    • Time Frame: 7 days
    • Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms.

Secondary Measures

  • Severity of opiod withdrawal
    • Time Frame: 7 days
    • Compares changes of severity of opioid withdrawal syndrome in two arms
  • Amount of Ketorolac administered
    • Time Frame: 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
    • Time Frame: 7 days
    • Compares number and severity of adverse events in two treatment arms

Participating in This Clinical Trial

Inclusion Criteria

  • Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Petersburg Bekhterev Research Psychoneurological Institute
  • Provider of Information About this Clinical Study
    • Sponsor

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