Role of BP1.3656 on Alcohol Responses

NCT ID: NCT04727086

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-08-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Medication (BP1.3656)

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.

Group Type: EXPERIMENTAL

BP1.3656

Intervention Type: DRUG

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.

Placebo pills

Participants will receive matching placebo pills for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered once daily in tablet form.

Interventions

BP1.3656

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.

Intervention Type: DRUG

Placebo

Administered once daily in tablet form.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

072/2017

Identifier Type: -

Identifier Source: org_study_id