Pregabalin for Opiate Withdrawal Syndrome

• Sponsor: St. Petersburg Bekhterev Research Psychoneurological Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03017430
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 71
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Number of patients completed detoxification [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 [7 days]

   Compares changes of severity of opioid withdrawal syndrome in two arms

2. Amount of Ketorolac administered [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 [7 days]

   Compares number and severity of adverse events in two treatment arms

Other Outcome Measures

1. Craving for opiates [7 days]

   Craving for opiates will be measured with the visual analog scale. Compares craving for opiates in two treatment arms during detoxification.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St.-Petersburg Bekhterev Reserach Psychoneurological Institute	St.-Petersburg		Russian Federation	192019

Sponsors and Collaborators

• St. Petersburg Bekhterev Research Psychoneurological Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Petersburg Bekhterev Research Psychoneurological Institute
• ClinicalTrials.gov Identifier: NCT03017430
• Other Study ID Numbers: BRPI-PGBL-OW01
• First Posted: Jan 11, 2017
• Last Update Posted: Apr 7, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Substance Withdrawal Syndrome; Ketorolac; Phenazepam; Clonidine; Pregabalin; Metoclopramide; Loperamide; Antidiarrheals

Study Results

No Results Posted as of Apr 7, 2020