AlcoholismPhase 4NCT02205879
Pregabalin for Alcohol Dependence
A Phase 4 study testing Pregabalin in people with Alcoholism, run by St. Petersburg Bekhterev Research Psychoneurological Institute at 1 site in Russia.
Trial summary
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2013to 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
- Alcohol Dependence by ICD-X criteria
Who cannot join
- Severe co-morbid psychiatric and somatic diseases
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: Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity
Read the detailed description
This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence
- Conditions
- Alcoholism
- Being tested
- Pregabalin, Placebo
- Keywords
- pregabalin, patients, treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| pregabalin | Experimental | Not described Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Number of subjects retianed in treatment (not relapsed)
Measured: three months
Secondary outcomes (1)
Weekly alcohol consumption
Time Line Follow Back technique
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJan 2013
- 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 AlcoholismStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg Bekhterev Research Psychoneurological Institute
- Sponsor type
- University, hospital or other
- Collaborators
- St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205879
- Sponsor's protocol ID
- BRPI-PGBL-A01
- Status last verified
- Apr 2020
- First submitted
- 30 Jul 2014
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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
- Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02205879
- Acronym / sponsor ID
- BRPI-PGBL-A01
- Conditions
- Alcoholism
- Keywords
- pregabalin, patients, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Petersburg Bekhterev Research Psychoneurological InstituteUniversity, hospital or other
- Collaborators
- St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 31 Jul 2014 (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.
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity
Detailed description
This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin | Experimental | Drug: Pregabalin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Alcohol Dependence by ICD-X criteria
Key exclusion criteria (1 listed)
- Severe co-morbid psychiatric and somatic diseases
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 |
|---|---|---|
| Pregabalin | Drug | pregabalin |
| Placebo | Drug | Placebo |
Primary outcome
Retention in treatment
Time frame: three months
Number of subjects retianed in treatment (not relapsed)
1 secondary outcome
Weekly alcohol consumption
Time frame: three months
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 in people with Alcoholism, 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. Some participants in this study may receive a placebo. 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?
Retention in treatment (time frame: three months). 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; AzTrials last refreshed its copy on 27 Oct 2026.