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Pregabalin for Opiate Withdrawal Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017430
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
St. Petersburg Bekhterev Research Psychoneurological Institute

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.

Condition or disease Intervention/treatment Phase
Opioid Withdrawal Drug: Pregabalin Drug: Clonidine Drug: Doxylamin Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome
Actual Study Start Date : January 2014
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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: 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)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Severity of opiod withdrawal [ Time Frame: 7 days ]
    Compares changes of severity of opioid withdrawal syndrome in two arms

  2. 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.

  3. Number and severity of adverse events [ Time Frame: 7 days ]
    Compares number and severity of adverse events in two treatment arms


Other Outcome Measures:
  1. Craving for opiates [ Time Frame: 7 days ]
    Craving for opiates will be measured with the visual analog scale. Compares craving for opiates in two treatment arms during detoxification.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017430


Locations
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Russian Federation
St.-Petersburg Bekhterev Reserach Psychoneurological Institute
St.-Petersburg, Russian Federation, 192019
Sponsors and Collaborators
St. Petersburg Bekhterev Research Psychoneurological Institute
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Responsible Party: St. Petersburg Bekhterev Research Psychoneurological Institute
ClinicalTrials.gov Identifier: NCT03017430    
Other Study ID Numbers: BRPI-PGBL-OW01
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ketorolac
Phenazepam
Clonidine
Pregabalin
Metoclopramide
Loperamide
Antidiarrheals
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors