Alcohol Use DisorderPhase 2NCT04727086
Role of BP1.3656 on Alcohol Responses
A Phase 2 study testing BP1.3656 in people with Alcohol Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- BP1.3656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 31 Aug 2022
- 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 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AUD with endorsement of 4-8 symptoms
- Average weekly consumption ≥ 14 standard drinks for women and ≥ 21 standard drinks for men over the past 3 months
- Willingness to take study medication and participate in laboratory sessions requiring alcohol administration
- Able to give written informed consent
- Certified as healthy by a comprehensive clinical assessment. Alanine transaminase (ALT) and aspartate aminotransferase (AST) levels should not be more than 1.2 times normal
Who cannot join
- Seeking treatment for alcohol use (or current efforts to cut down or seek treatment)
- A Clinical Institute Withdrawal Assessment (CIWA) score of 8+ upon initial assessment
- Current medical conditions or medications that contraindicate receiving the study drug (based on the study physician's assessment)
- Meeting criteria for a current substance use disorder aside from alcohol or nicotine
- Recent recreational drug use (assessed via urine toxicology screen)
- History of gross psychiatric or neurological impairment (e.g., schizophrenia, bipolar disorder, neurological disorders)
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- Reported difficulty with intravenous procedures
- Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)
- Currently nursing or pregnant (females)
- Serious unstable medical condition
- Current use of medication that could increase the risk of BP1.3656B administration
- Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
- Any history of seizures
Trial locations and contacts
1 site in 1 country.
About this study
The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).
Read the detailed description
The current study employs BP1.3656, a novel investigational compound with a track record for safety and tolerability in phase I clinical trials. When administered to mice, BP1.3656 was associated with increased metabolism of histamine and elevated brain dopamine and acetylcholine, suggestive of utility in psychiatric disorders including Alcohol Use Disorder (AUD).
This study is a Phase II laboratory-based trial of BP1 .3656 for AUD. 40 non-treatment seeking participants with AUD will be recruited. Participants will be randomly assigned to intervention with BP1 .3656 or placebo in a within-subject, crossover design. During each intervention period, outcome measures relating to alcohol motivation and self-administration will be assessed in the laboratory. It is hypothesized that relative to placebo, alcohol self-administration will be decreased by BP1 .3656.
- Conditions
- Alcohol Use Disorder
- Being tested
- BP1.3656, Placebo
- Keywords
- Ethanol, Alcohol, Self administration, BP1.3656B, Alcohol Use Disorder, Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
- Medical subject headings
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.3656Drug
BP1.3656 will be administered in tablet form once daily at a dose of 30 µg/day for the first 4 days of the intervention phase, followed by a dose increase to 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg.
PlaceboDrug
Administered once daily in tablet form.
| Study group | Role | What they receive |
|---|---|---|
| Medication (BP1.3656) | Experimental | Participants will receive BP1.3656 in tablet form once daily at a dose of 30 µg/day for the first 4 days, followed by 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg. Receives: Drug: BP1.3656 |
| Placebo pills | Placebo comparator | Participants will receive matching placebo pills for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking study medication (BP1.3656).
Breath alcohol concentration (BrAC) test reading will be assessed
Measured: Measured during one self-administration session in the 2nd week of the 14-day study medication phase.
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking placebo.
Breath alcohol concentration (BrAC) test reading will be assessed
Measured: Measured during one self-administration session in the 2nd week of the 14-day placebo phase.
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking study medication (BP1.3656).
Measured by number of button presses/work sets
Measured: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day medication phase
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking placebo.
Measured by number of button presses/work sets
Measured: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day placebo-phase.
Secondary outcomes (8)
Subjective effects of alcohol during free-access and progressive ratio self-administration sessions while taking study medication (BP1.3656), as measured by the Biphasic Alcohol Effects Scale (0-10 scoring)
Two subscales (stimulant and sedative) with a 0-10 scoring where higher scores for stimulant subscale indicate increased stimulated effects from alcohol, while higher scores for sedative subscale indicate more sedated effects from alcohol.
Measured: Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day medication phase.
Subjective effects of alcohol (maximum reported stimulation and sedation from alcohol) during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Biphasic Alcohol Effects Scale (0-10 scoring)
Two subscales (stimulant and sedative) with a 0-10 scoring where higher scores for stimulant subscale indicate increased stimulation, while higher scores for sedative subscale indicate more sedated effects from alcohol.
Measured: Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day placebo phase.
Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking BP1.3656, as measured by the Alcohol Urge Questionnaire (1-7 scoring)
8 statements with score options ranging from Score of 1 = Strongly disagree to Score of 7 = Strongly Agree. Higher scores reflect greater craving.
Measured: Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of medication phase.
Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Alcohol Urge Questionnaire (1-7 scoring)
8 statements with score options ranging from Score of 1 = Strongly disagree to Score of 7 = Strongly Agree. Higher scores reflect greater craving.
Measured: Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of placebo phase.
Safety and tolerability of BP1.3656
Side effects of BP1.3656 will be assessed with the Systematic Assessment for Treatment Emergent Effects questionnaire (not reporting score on a scale) and the Pittsburgh Sleep Quality Index (19 items with 0-3 scoring, where higher scores indicate worse sleep quality).
Measured: During the free-access and progressive ratio sessions in the 2nd week of the 14-day study medication phase
Safety and tolerability of BP1.3656
Side effects of BP1.3656 will be assessed with the Systematic Assessment for Treatment Emergent Effects questionnaire (not reporting score on a scale) and the Pittsburgh Sleep Quality Index (19 items with 0-3 scoring, where higher scores indicate worse sleep quality).
Measured: During the free-access and progressive ratio sessions in the 2nd week of the 14-day study placebo phase
Weekly alcohol consumption during treatment with BP1 .3656
Drinks per week, as measured by the Timeline Follow-Back method
Measured: Measured during the 2nd week of the 14-day study medication phase
Weekly alcohol consumption during treatment with placebo
Drinks per week, as measured by the Timeline Follow-Back method
Measured: Measured during the 2nd week of the 14-day placebo phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a within-subjects, counterbalanced, crossover trial with a washout period. Participants will receive either placebo or the interventional drug BP1.3656 during the initial 14-day phase of the study and receive the other intervention during the second 14-day phase of the study. The washout period will last a minimum of 14 days. Participants will come in to the laboratory on two separate days near the end of each intervention phase to complete alcohol self-administration sessions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727086
- Sponsor's protocol ID
- 072/2017
- Status last verified
- Apr 2023
- First submitted
- 19 Jan 2021
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of BP1.3656 on Alcohol Responses
- ClinicalTrials.gov ID
- NCT04727086
- Acronym / sponsor ID
- 072/2017
- Conditions
- Alcohol Use Disorder
- Keywords
- Ethanol, Alcohol, Self administration, BP1.3656B, Alcohol Use Disorder, Alcoholism, Alcohol Drinking, Drinking Behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 27 Jan 2021 (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.
The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).
Detailed description
The current study employs BP1.3656, a novel investigational compound with a track record for safety and tolerability in phase I clinical trials. When administered to mice, BP1.3656 was associated with increased metabolism of histamine and elevated brain dopamine and acetylcholine, suggestive of utility in psychiatric disorders including Alcohol Use Disorder (AUD).
This study is a Phase II laboratory-based trial of BP1 .3656 for AUD. 40 non-treatment seeking participants with AUD will be recruited. Participants will be randomly assigned to intervention with BP1 .3656 or placebo in a within-subject, crossover design. During each intervention period, outcome measures relating to alcohol motivation and self-administration will be assessed in the laboratory. It is hypothesized that relative to placebo, alcohol self-administration will be decreased by BP1 .3656.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a within-subjects, counterbalanced, crossover trial with a washout period. Participants will receive either placebo or the interventional drug BP1.3656 during the initial 14-day phase of the study and receive the other intervention during the second 14-day phase of the study. The washout period will last a minimum of 14 days. Participants will come in to the laboratory on two separate days near the end of each intervention phase to complete alcohol self-administration sessions.
| Arm | Type | Receives |
|---|---|---|
| Medication (BP1.3656) | Experimental | Drug: BP1.3656Participants will receive BP1.3656 in tablet form once daily at a dose of 30 µg/day for the first 4 days, followed by 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg. |
| Placebo pills | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo pills for 14 days. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AUD with endorsement of 4-8 symptoms
- Average weekly consumption ≥ 14 standard drinks for women and ≥ 21 standard drinks for men over the past 3 months
- Willingness to take study medication and participate in laboratory sessions requiring alcohol administration
- Able to give written informed consent
- Certified as healthy by a comprehensive clinical assessment. Alanine transaminase (ALT) and aspartate aminotransferase (AST) levels should not be more than 1.2 times normal
Key exclusion criteria (13 listed)
- Seeking treatment for alcohol use (or current efforts to cut down or seek treatment)
- A Clinical Institute Withdrawal Assessment (CIWA) score of 8+ upon initial assessment
- Current medical conditions or medications that contraindicate receiving the study drug (based on the study physician's assessment)
- Meeting criteria for a current substance use disorder aside from alcohol or nicotine
- Recent recreational drug use (assessed via urine toxicology screen)
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 |
|---|---|---|
| BP1.3656BP1.3656 will be administered in tablet form once daily at a dose of 30 µg/day for the first 4 days of the intervention phase, followed by a dose increase to 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg. | Drug | Medication (BP1.3656) |
| PlaceboAdministered once daily in tablet form. | Drug | Placebo pills |
Primary outcome
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking study medication (BP1.3656).
Time frame: Measured during one self-administration session in the 2nd week of the 14-day study medication phase.
Breath alcohol concentration (BrAC) test reading will be assessed
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking placebo.
Time frame: Measured during one self-administration session in the 2nd week of the 14-day placebo phase.
Breath alcohol concentration (BrAC) test reading will be assessed
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking study medication (BP1.3656).
Time frame: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day medication phase
Measured by number of button presses/work sets
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking placebo.
Time frame: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day placebo-phase.
Measured by number of button presses/work sets
8 secondary outcomes
Subjective effects of alcohol during free-access and progressive ratio self-administration sessions while taking study medication (BP1.3656), as measured by the Biphasic Alcohol Effects Scale (0-10 scoring)
Time frame: Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day medication phase.
Subjective effects of alcohol (maximum reported stimulation and sedation from alcohol) during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Biphasic Alcohol Effects Scale (0-10 scoring)
Time frame: Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day placebo phase.
Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking BP1.3656, as measured by the Alcohol Urge Questionnaire (1-7 scoring)
Time frame: Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of medication phase.
Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Alcohol Urge Questionnaire (1-7 scoring)
Time frame: Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of placebo phase.
Safety and tolerability of BP1.3656
Time frame: During the free-access and progressive ratio sessions in the 2nd week of the 14-day study medication phase
Safety and tolerability of BP1.3656
Time frame: During the free-access and progressive ratio sessions in the 2nd week of the 14-day study placebo phase
Weekly alcohol consumption during treatment with BP1 .3656
Time frame: Measured during the 2nd week of the 14-day study medication phase
Weekly alcohol consumption during treatment with placebo
Time frame: Measured during the 2nd week of the 14-day placebo phase
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 5 Apr 2023.
- Individual participant dataSharing planned: No
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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 2 study testing BP1.3656 in people with Alcohol Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 5 inclusion and 13 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 5 Apr 2023. 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 Canada. 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?
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking study medication (BP1.3656). (time frame: Measured during one self-administration session in the 2nd week of the 14-day study medication phase.). The study lists 4 primary outcomes in all. 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 5 Apr 2023.