Opioid WithdrawalPhase 4NCT03017430
Pregabalin for Opiate Withdrawal Syndrome
A Phase 4 study testing Pregabalin, Clonidine and Doxylamin in people with Opioid Withdrawal, run by St. Petersburg Bekhterev Research Psychoneurological Institute at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Opioid Withdrawal
- What is being tested?
- Pregabalin, Clonidine and Doxylamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2014to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Opioid Use Disorders; Opioid Withdrawal Syndrome
Who cannot join
- Severe psychiatric and somatic disorders, other Substance Use Disorders (except tobacco)
Trial locations and contacts
1 site in 1 country.
Russia1 site
St.-Petersburg Bekhterev Reserach Psychoneurological Institute
Saint Petersburg, 192019
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Withdrawal
- Being tested
- Pregabalin, Clonidine, Doxylamin, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).
ClonidineDrug
Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
DoxylaminDrug
Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)Drug
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | 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). Receives: Drug: Pregabalin; Drug: Doxylamin; Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine) |
| Clonidine | Active comparator | 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).. Receives: Drug: Clonidine; Drug: Doxylamin; Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients completed detoxification
Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms.
Measured: 7 days
Secondary outcomes (3)
Severity of opiod withdrawal
Compares changes of severity of opioid withdrawal syndrome in two arms
Measured: 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.
Measured: 7 days
Number and severity of adverse events
Compares number and severity of adverse events in two treatment arms
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg Bekhterev Research Psychoneurological Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017430
- Sponsor's protocol ID
- BRPI-PGBL-OW01
- Status last verified
- Apr 2020
- First submitted
- 6 Jan 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome
- ClinicalTrials.gov ID
- NCT03017430
- Acronym / sponsor ID
- BRPI-PGBL-OW01
- Conditions
- Opioid Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Petersburg Bekhterev Research Psychoneurological InstituteUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin, Drug: Doxylamin, Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)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). |
| Clonidine | Active comparator | Drug: Clonidine, Drug: Doxylamin, Drug: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)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).. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Opioid Use Disorders; Opioid Withdrawal Syndrome
Key exclusion criteria (1 listed)
- Severe psychiatric and somatic disorders, other Substance Use Disorders (except tobacco)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinPregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine). | Drug | Pregabalin |
| ClonidineClonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine) | Drug | Clonidine |
| Doxylamin | Drug | Clonidine, Pregabalin |
| Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine) | Drug | Clonidine, Pregabalin |
Primary outcome
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.
3 secondary outcomes
Severity of opiod withdrawal
Time frame: 7 days
Amount of Ketorolac administered
Time frame: 7 days
Number and severity of adverse events
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin, Clonidine and Doxylamin in people with Opioid Withdrawal, run by St. Petersburg Bekhterev Research Psychoneurological Institute at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients completed detoxification (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.