Status:
COMPLETED
Role of BP1.3656 on Alcohol Responses
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
19-45 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04727086
Start Date
February 1 2021
End Date
August 31 2022
Last Update
April 5 2023
Active Locations (1)
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1
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1