Role of BP1.3656 on Alcohol Responses

NCT04727086 | Completed Phase 2 DMC

• 1 other identifier: 072/2017
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use Disorder

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

Outcome Measures

Primary Outcomes (4)

• 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 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 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 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 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)

  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)

  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)

  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)

  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

  During the free-access and progressive ratio sessions in the 2nd week of the 14-day study medication phase

Study Arms (2)

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.

Drug: BP1.3656

Placebo pills

PLACEBO COMPARATOR

Participants will receive matching placebo pills for 14 days.

Drug: Placebo

Interventions

BP1.3656 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.

Medication (BP1.3656)

Placebo DRUG

Administered once daily in tablet form.

Placebo pills

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)