Pregabalin for Opiate Withdrawal Syndrome

Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Opioid Withdrawal
• Intervention / Treatment: Drug: Pregabalin; Drug: Doxylamin; Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine); Drug: Clonidine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • St.-Petersburg, Russian Federation, 192019
    • St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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: Doxylamin; Drug: 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)..	Drug: Doxylamin; Drug: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of opiod withdrawal	Compares changes of severity of opioid withdrawal syndrome in two arms	7 days
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
Number and severity of adverse events	Compares number and severity of adverse events in two treatment arms	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Petersburg Bekhterev Research Psychoneurological Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Anti-Anxiety Agents; GABA Agents; Adjuvants, Immunologic; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sympatholytics; Ketorolac; Pregabalin; Clonidine; Phenazepam; Metoclopramide; Loperamide; Antidiarrheals
• Other Study ID Numbers: BRPI-PGBL-OW01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No