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Completed

NCT Number: NCT04727086

Role of BP1.3656 on Alcohol Responses

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

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Key information

Conditions

Alcohol Use Disorder Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

Administered once daily in tablet form.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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