Alcohol Use DisorderPhase 2NCT03424824
Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
A Phase 2 study testing BP1.3656 low dose, BP1.3656 intermediate dose and BP1.3656 high dose in people with Alcohol Use Disorder, run by Bioprojet at 3 sites in 3 countries.
Trial summary
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- BP1.3656 low dose, BP1.3656 intermediate dose and BP1.3656 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Jan 2018to 24 Nov 2021
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female alcohol use disorder
- Ages 18-65
- Absent or minimal alcohol withdrawal symptoms assessed
- 18 kg/m2 ≤ BMI ≤ 35 kg/m2
- Excessive alcohol use during the 2 weeks between screening and baseline
- Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).
Who cannot join
- History of delirium tremens, epilepsy, or withdrawal seizures
- Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
- Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
- Clinically significant cardiovascular, hematologic, severe hepatic impairment
- History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
- Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox
- Receiving ongoing alcohol use disorder medication (e.g. Baclofen)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Bulgaria1 site
State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism
Sofia, 1303
About this study
Official title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.
Read the detailed description
Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.
- Conditions
- Alcohol Use Disorder
- Being tested
- BP1.3656 low dose, BP1.3656 intermediate dose, Placebo, BP1.3656 high dose
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.3656 low doseDrug
Tablet, once daily oral administration at the low dose
BP1.3656 intermediate doseDrug
Tablet, once daily oral administration at the intermediate dose
PlaceboDrug
Tablet, once daily oral administration
BP1.3656 high doseDrug
Tablet, once daily oral administration at the high dose
| Study group | Role | What they receive |
|---|---|---|
| BP1.3656 low dose | Experimental | administration of BP1.3656 at 30 µg Receives: Drug: BP1.3656 low dose |
| BP1.3656 intermediate dose | Experimental | administration of BP1.3656 at 60 µg Receives: Drug: BP1.3656 intermediate dose |
| Placebo | Placebo comparator | administration of placebo Receives: Drug: Placebo |
| BP1.3656 high dose | Experimental | administration of BP1.3656 at 90 µg Receives: Drug: BP1.3656 high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in number of monthly Heavy Drinking Days (HDDs/month)
Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.
Measured: 12 weeks
Secondary outcomes (2)
Total daily alcohol consumption (TAC)
Total daily alcohol consumption (TAC) from baseline to the end of treatment
Measured: 12 weeks
Percent of patients without Heavy Drinking Days (HDDs)
Percent of patients without HDDs during the 12-week medication phase
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start9 Jan 2018
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evgeny Krupitsky, Pr, Principal investigator, Leningrad Regional Narcology Dispensary, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424824
- Sponsor's protocol ID
- P15-01 / BP1.3656
- Other IDs
- 2017-000069-57, 2017
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2018
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT03424824
- Acronym / sponsor ID
- P15-01 / BP1.3656
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 7 Feb 2018 (actual)
- 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.
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.
Detailed description
Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BP1.3656 low dose | Experimental | Drug: BP1.3656 low doseadministration of BP1.3656 at 30 µg |
| BP1.3656 intermediate dose | Experimental | Drug: BP1.3656 intermediate doseadministration of BP1.3656 at 60 µg |
| Placebo | Placebo comparator | Drug: Placeboadministration of placebo |
| BP1.3656 high dose | Experimental | Drug: BP1.3656 high doseadministration of BP1.3656 at 90 µg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female alcohol use disorder
- Ages 18-65
- Absent or minimal alcohol withdrawal symptoms assessed
- 18 kg/m2 ≤ BMI ≤ 35 kg/m2
- Excessive alcohol use during the 2 weeks between screening and baseline
Key exclusion criteria (7 listed)
- History of delirium tremens, epilepsy, or withdrawal seizures
- Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
- Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
- Clinically significant cardiovascular, hematologic, severe hepatic impairment
- History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
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 |
|---|---|---|
| BP1.3656 low doseTablet, once daily oral administration at the low dose | Drug | BP1.3656 low dose |
| BP1.3656 intermediate doseTablet, once daily oral administration at the intermediate dose | Drug | BP1.3656 intermediate dose |
| PlaceboTablet, once daily oral administration | Drug | Placebo |
| BP1.3656 high doseTablet, once daily oral administration at the high dose | Drug | BP1.3656 high dose |
Primary outcome
Decrease in number of monthly Heavy Drinking Days (HDDs/month)
Time frame: 12 weeks
Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.
2 secondary outcomes
Total daily alcohol consumption (TAC)
Time frame: 12 weeks
Percent of patients without Heavy Drinking Days (HDDs)
Time frame: 12 weeks
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 21 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
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.
Evgeny Krupitsky, Pr principal investigator
Leningrad Regional Narcology Dispensary, Russia
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BP1.3656 low dose, BP1.3656 intermediate dose and BP1.3656 high dose in people with Alcohol Use Disorder, run by Bioprojet at 3 sites in 3 countries.
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 6 inclusion and 7 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bulgaria, France, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Decrease in number of monthly Heavy Drinking Days (HDDs/month) (time frame: 12 weeks). 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 21 Jan 2022.