Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg for Alcohol Drinking

Phase-Based Estimates
1
Effectiveness
1
Safety
VA Connecticut Healthcare System, West Haven, CT
Alcohol Drinking+6 More
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alcohol Drinking

Study Summary

This study is evaluating whether a drug may help reduce alcohol consumption in individuals with comorbid posttraumatic stress disorder.

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Eligible Conditions

  • Alcohol Drinking
  • Disease
  • Moral Injury
  • Stress Disorders, Traumatic
  • Alcoholism
  • Alcohol Use Disorders (AUD)
  • Stress Disorders, Post-Traumatic
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg will improve 26 primary outcomes in patients with Alcohol Drinking. Measurement will happen over the course of On each Test Day (1-3), from baseline (prior to drug administration) to the Go No-Go assessment conducted immediately after the targeted BAL is reached during the alcohol infusion..

On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion.
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Biphasic Alcohol Effects Scale (BAES), in the presence of ethanol.
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Drug Effects Questionnaire (DEQ), in the presence of ethanol.
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Number of Drinks Scale (NDS), in the presence of ethanol.
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the State Trait Anxiety Inventory (STAI-6), in the presence of ethanol.
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Visual Analog Scale (VAS), in the presence of ethanol.
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Yale Craving Scale (YCS), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the ACES measurement taken after completion of the alcohol infusion.
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by the Agitation-Calmness Evaluation Scale (ACES), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the RASS measurement taken after completion of the alcohol infusion.
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by the Richmond Agitation Sedation Scale (RASS), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the blood pressure measurement taken after completion of the alcohol infusion.
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by blood pressure (systolic and diastolic), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the heart rate measurement taken after completion of the alcohol infusion.
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by heart rate, in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions.
Change in alcohol craving, as measured by the Yale Craving Scale (YCS), by treatment group during alcohol cue induced craving.
Change in anxiety, as measured by blood pressure (systolic and diastolic), by treatment group during alcohol cue induced craving.
Change in anxiety, as measured by heart rate, by treatment group during alcohol cue induced craving.
Change in anxiety, as measured by the State Trait Anxiety Inventory (STAI-6), by treatment group during alcohol cue induced craving.
Change in mood disturbance, as measured by Drugs Effects Questionnaire (DEQ), by treatment group during alcohol cue induced craving.
Change in mood disturbance, as measured by Visual Analog Scale (VAS), by treatment group during alcohol cue induced craving.
On each Test Day (1-3), from baseline (prior to drug administration) to assessments conducted immediately after the alcohol infusion.
Evaluate whether pretreatment with BXCL501 alters motor impairment, as measured by the Grooved Pegboard (GPB), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to drug administration) to the Go No-Go assessment conducted immediately after the targeted BAL is reached during the alcohol infusion.
Evaluate whether pretreatment with BXCL501 alters cognitive functioning, as measured by the Go No-Go Task, in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to drug administration) to the HVLT-R assessment conducted immediately after the targeted BAL is reached during the alcohol infusion.
Evaluate whether pretreatment with BXCL501 alters cognitive functioning, as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to drug administration) to the RVIP assessment conducted immediately after the targeted BAL is reached during the alcohol infusion.
Evaluate whether pretreatment with BXCL501 alters cognitive functioning, as measured by the Rapid Information Processing Task (RVIP), in the presence of ethanol.
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions
Change in anxiety, as measured by blood pressure (systolic and diastolic), by treatment group during stress reactivity conditions.
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions .
Change in anxiety, as measured by heart rate, by treatment group during stress reactivity conditions.
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions.
Change in alcohol craving, as measured by the Yale Craving Scale (YCS), by treatment group during stress reactivity conditions.
Change in anxiety, as measured by the State Trait Anxiety Inventory (STAI-6), by treatment group during stress reactivity conditions.
Change in mood disturbance, as measured by Drugs Effects Questionnaire (DEQ), by treatment group during stress reactivity conditions.
Change in mood disturbance, as measured by Visual Analog Scale (VAS), by treatment group during stress reactivity conditions.

Trial Safety

Trial Design

3 Treatment Groups

Placebo
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
Placebo group

This trial requires 10 total participants across 3 different treatment groups

This trial involves 3 different treatments. Dexmedetomidine (DEX) For Sublingual (SL) Administration (BXCL501) - 40µg is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µgBXCL501 is a thin film formulation of dexmedetomidine (DEX) for sublingual (SL) administration. The product is a small, solid-dose film formulation, approximately 286 mm2 in area and 0.7 mm thick, designed to solubilize in the SL space within 1-3 minutes. At the time of dosing, subjects will be verbally instructed on how to take the investigational product sublingually, and that they should retain the investigational product in the sublingual cavity until dissolved.
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µgBXCL501 is a thin film formulation of dexmedetomidine (DEX) for sublingual (SL) administration. The product is a small, solid-dose film formulation, approximately 286 mm2 in area and 0.7 mm thick, designed to solubilize in the SL space within 1-3 minutes. At the time of dosing, subjects will be verbally instructed on how to take the investigational product sublingually, and that they should retain the investigational product in the sublingual cavity until dissolved.
PlaceboPlacebo and study drug will look exactly the same in order to maintain the double-blind; study drug and placebo are administered exactly the same.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: on each test day (1-3), from baseline (prior to stress condition) to the end of the ptsd stress reactivity conditions
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly on each test day (1-3), from baseline (prior to stress condition) to the end of the ptsd stress reactivity conditions for reporting.

Closest Location

VA Connecticut Healthcare System - West Haven, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are willing to comply with all study procedures and be available for the duration of the study. show original
ECG that demonstrates no clinically significant conduction issues or arrhythmias. show original
Male or female, Veterans and non-Veterans, ages 21 to 65;
You are able to read and write in English and sign the informed consent. show original
Have no clinically significant contraindications, in the judgement of the PI/study physician, for study participation (based on self-reported medical history and brief physical examination);
Have a current diagnosis of Alcohol use disorder (AUD) (mild, moderate, or severe) as determined by MINI-5 and PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
PCL-5 score >33;
You must have > 1 heavy drinking episode (>4 SDU) in the last 30 days. show original
Not be treatment seeking for AUD
Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for > 6 months) must be willing to use a medically acceptable and effective birth control method for 3 months before the study and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills or patches, birth control implants, diaphragm, intrauterine device (IUD), or condoms.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get alcohol drinking a year in the United States?

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There are an estimated 43 million binge drinking in the United States over one year. These numbers represent a significant problem in modern American life.

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What is alcohol drinking?

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Alcohol consumption may be a risk factor for developing cancers of the oral cavity, esophagus, pharynx and larynx. Alcohol intake contributes to a significant proportion of oral cancer cases and some types of oropharyngeal cancer are particularly closely associated with alcohol consumption. There is clear evidence for an increased risk of developing cancers of the larynx, oesophagus and stomach among regular consumers of alcoholic beverages.

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Can alcohol drinking be cured?

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Drinking for alcohol reasons is a significant and neglected health problem and represents a health risk as well as an economic burden. Considering its rarity, it should not be cured; instead the problem should be understood as a health risk and prevented by modifying the environment or limiting alcohol consumption to special circumstances (e.g., medical treatment).

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What are the signs of alcohol drinking?

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Individuals drinking are more likely to be obese and less likely to be fit than non-drinking men. On the other hand, alcoholics are less likely to be athletic and to be fit.

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What causes alcohol drinking?

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Findings from a recent study highlights the need to understand and prevent alcohol-related problems among parents and their children in order to prevent further alcohol drinking.

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What are common treatments for alcohol drinking?

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Alcoholics tend to be undertreated or undertreated for alcohol abuse issues in general. Recent findings of this survey suggest that clinicians may have more insight into alcohol use in younger patients but fail to adequately counsel individuals who tend to delay therapy until they fail to abstain.

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Have there been any new discoveries for treating alcohol drinking?

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Although there are a number of new treatments for alcoholism, the fact remains that many people are still suffering with the disease for a long time. As more treatments are discovered, it will remain a challenge to find a new cure for alcohol abusing patients. [http://www.withpower.com/medical-dietetics/diabetes-alcohol.aspx, http://www.withpower.com/personal-medicine/diabetes-alcohol.aspx].

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Does alcohol drinking run in families?

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We observed that alcohol drinkers are more than twice as likely to drink alcohol with relatives than nonrelatives. Moreover, drinking and heavy drinking are more common in relatives than nonrelatives.

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Have there been other clinical trials involving dexmedetomidine (dex) for sublingual (sl) administration (bxcl501) - 40µg?

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The study reported was the preliminary analysis of the first randomized, double-blind, placebo-controlled study to demonstrate the safety and effectiveness of the sublingual formulation of dextramede(dex) in patients undergoing ambulatory anesthesia for routine surgical procedures.

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Is dexmedetomidine (dex) for sublingual (sl) administration (bxcl501) - 40µg typically used in combination with any other treatments?

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Dex in all doses of at least 20 mg/kg/24 hr administered to 2x as many as 3 sl doses every 4 hr in combination with sl buprenorphine was found to improve outcomes in patients with opioid-dependent opioid-dependent patients who were transitioning to detoxification or were experiencing withdrawal symptoms.

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Does dexmedetomidine (dex) for sublingual (sl) administration (bxcl501) - 40µg improve quality of life for those with alcohol drinking?

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Recent findings suggest that dexmedetomidine has a positive impact on quality of life. Recent findings suggest that the combination of sl x 40µg dex is effective in treatment of alcohol drinkers.

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What is dexmedetomidine (dex) for sublingual (sl) administration (bxcl501) - 40µg?

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Dex is safe in the SL formulation of bxcl501. It is well tolerated with few side effects. Dex has a short onset time when administered sublingually, which is helpful for patients and caregivers.

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