Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study

Summary

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. Safety endpoints will be compared following an alcohol challenge without and concurrent with BXCL501 treatment.

Conditions

• Alcohol Use Disorder (AUD)
• Post Traumatic Stress Disorder (PTSD)

Interventions

DRUG

Placebo

Placebo will be administered orally, as individual films in the SL space.

DRUG

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

BXCL 501 40µg will be administered orally, as individual films in the SL space.

DRUG

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

BXCL 501 80µg will be administered orally, as individual films in the SL space.

PROCEDURE

Ethanol Infusion

Study team will be using a modified alcohol-IV clamp procedure developed and standardized by Subramanian and colleagues (Subramanian, Heil et al. 2002). The infusion will be performed using a 6% ethanol solution in 0.9% saline. The computer assisted administration program automatically calculates and corrects the infusion rate based on real-time BrAC data entry by staff, based on the pharmacokinetic profile of each subject (targeting a breath alcohol concentration (BrAC) of 100 mg%).

BEHAVIORAL

PTSD Reactivity Condition

Participants will be exposed to two conditions in random order: PTSD cues and neutral cues. The cues will consist of a 5 minute presentation of the stimulus (trauma or neutral) followed by immediate evaluation of craving and anxiety. There will be a relaxation procedure between each condition. The imagery scripts are developed based on the scene construction questionnaire developed by Lang et al (Lang, Kozak et al. 1980, Lang, Levin et al. 1983) using a standardized format designed by Sinha (Sinha 2001).

BEHAVIORAL

Alcohol Cue Reactivity

Participants will be exposed to two conditions: a neutral cue (water) followed by an alcohol cue. Individuals will be instructed that they may smell and handle the beverage, but they cannot consume the beverage. Following the presentation, the research assistant takes the beverage and leaves the room, while the subject completes the anxiety and alcohol craving assessments.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Congressionally Directed Medical Research Programs

  collaborator FED

• RTI International

  collaborator OTHER

• VA Connecticut Healthcare System

  collaborator FED

• BioXcel Therapeutics Inc

  collaborator INDUSTRY

• Yale University

  collaborator OTHER

• Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

  lead OTHER

Principal Investigators

• Ismene Petrakis, MD · VA Connecticut Healthcare System

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-09

Primary Completion

2023-05-02

Completion

2023-06-02

FDA Drug

Yes

Countries

• United States

Study Locations