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Role of BP1.3656 on Alcohol Responses

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ClinicalTrials.gov Identifier: NCT04727086
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Centre for Addiction and Mental Health

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: BP1.3656 Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Role of BP1.3656 on Alcohol Responses
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
Placebo Comparator: Placebo pills
Participants will receive matching placebo pills for 14 days.
 Drug: Placebo
Administered once daily in tablet form.


Outcome Measures
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Primary Outcome Measures :
  1. Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking study medication (BP1.3656). [ Time Frame: Measured during one self-administration session in the 2nd week of the 14-day study medication phase. ]
    Breath alcohol concentration (BrAC) test reading will be assessed

  2. Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking placebo. [ Time Frame: Measured during one self-administration session in the 2nd week of the 14-day placebo phase. ]
    Breath alcohol concentration (BrAC) test reading will be assessed

  3. Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking study medication (BP1.3656). [ Time Frame: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day medication phase ]
    Measured by number of button presses/work sets

  4. Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking placebo. [ Time Frame: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day placebo-phase. ]
    Measured by number of button presses/work sets


Secondary Outcome Measures :
  1. 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) [ Time Frame: Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day medication phase. ]
    Two subscales (stimulant and sedative) with a 0-10 scoring where higher scores for stimulant subscale indicate increased stimulated effects from alcohol, while higher scores for sedative subscale indicate more sedated effects from alcohol.

  2. 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) [ Time Frame: Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day placebo phase. ]
    Two subscales (stimulant and sedative) with a 0-10 scoring where higher scores for stimulant subscale indicate increased stimulation, while higher scores for sedative subscale indicate more sedated effects from alcohol.

  3. 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) [ Time Frame: Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of medication phase. ]
    8 statements with score options ranging from Score of 1 = Strongly disagree to Score of 7 = Strongly Agree. Higher scores reflect greater craving.

  4. 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) [ Time Frame: Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of placebo phase. ]
    8 statements with score options ranging from Score of 1 = Strongly disagree to Score of 7 = Strongly Agree. Higher scores reflect greater craving.

  5. Safety and tolerability of BP1.3656 [ Time Frame: During the free-access and progressive ratio sessions in the 2nd week of the 14-day study medication phase ]
    Side effects of BP1.3656 will be assessed with the Systematic Assessment for Treatment Emergent Effects questionnaire (not reporting score on a scale) and the Pittsburgh Sleep Quality Index (19 items with 0-3 scoring, where higher scores indicate worse sleep quality).

  6. Safety and tolerability of BP1.3656 [ Time Frame: During the free-access and progressive ratio sessions in the 2nd week of the 14-day study placebo phase ]
    Side effects of BP1.3656 will be assessed with the Systematic Assessment for Treatment Emergent Effects questionnaire (not reporting score on a scale) and the Pittsburgh Sleep Quality Index (19 items with 0-3 scoring, where higher scores indicate worse sleep quality).

  7. Weekly alcohol consumption during treatment with BP1 .3656 [ Time Frame: Measured during the 2nd week of the 14-day study medication phase ]
    Drinks per week, as measured by the Timeline Follow-Back method

  8. Weekly alcohol consumption during treatment with placebo [ Time Frame: Measured during the 2nd week of the 14-day placebo phase ]
    Drinks per week, as measured by the Timeline Follow-Back method


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727086


Contacts
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Contact: Bernard Le Foll, MD, PhD 416-535-8501 ext 33111 bernard.lefoll@camh.ca

Locations
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Canada, Ontario
Center for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Bernard Le Foll, MD, PhD    416-535-8501 ext 33111    bernard.lefoll@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
More Information
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Responsible Party: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04727086    
Other Study ID Numbers: 072/2017
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre for Addiction and Mental Health:
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
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders