Role of BP1.3656 on Alcohol Responses

072/2017

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

2021-02-01

2022-08-31

2022-08-31

Completed

Early phase I

37

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.\n\nParticipants will come in to the laboratory on two separate days near the end of each intervention phase to complete alcohol self-administration sessions.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-04-05