Skip to main content
OpenTrials
Completed

NCT Number: NCT03017430

Pregabalin for Opiate 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Withdrawal

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St.-Petersburg Bekhterev Reserach Psychoneurological Institute

Saint Petersburg, 192019, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion criteria

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

Treatment and study plan

Pregabalin

Drug

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

Drug

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

Drug

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

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Petersburg Bekhterev Research Psychoneurological Institute

Other

Registry information

Official study title

Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.