Role of BP1.3656 on Alcohol Responses

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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