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) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.
Veterans and non-Veterans, ages 21 to 65;
Able to read and write in English and sign the informed consent;
Willing to comply with all study procedures and be available for the duration of the study;
ECG that demonstrates no clinically significant conduction issues or arrhythmias;
Current bipolar disorder or psychotic disorders as determined by MINI-5;
Current diagnosis of a substance use disorder (other than alcohol, nicotine, or marijuana) as determined by MINI-5;
Females who are pregnant, nursing, or planning to become pregnant during study participation;
Current physiological alcohol dependence requiring a higher level of care (e.g., detox) as determined by study physician conducting physical examination and CIWA score. Tolerance to alcohol will be allowed.
Sequential
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg
DrugBXCL 501 40µg will be administered orally, as individual films in the Sub Lingual (SL) space.
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
DrugBXCL 501 80µg will be administered orally, as individual films in the SL space
Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.
Participants will undergo vital signs on baseline, day 5, day 7, and weeks 2-4. The change in blood pressure is computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.
Participants will take the STAI-6 assessment on baseline, day 5, day 7, and weeks 2-4. The change in STAI-6 score is computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Number and Proportion of Adverse Events
Adverse Events will be monitored and documented through each dose escalation phase after the first dose administration.
Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28.
Participants will take the PCL-5 assessment on baseline, day 5, day 7, and weeks 2-4. The change in PCL-5 score is computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28.
Participants will complete the TLFB structured interview at baseline, day 5, day 7, and weeks 2-4. Change in alcohol consumption will be computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28.
Participants will complete the OCDS assessment at baseline, day 5, day 7, and weeks 2-4. Change in OCDS total score will be computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28.
Participants will complete the DES-R assessment at baseline, day 5, day 7, and weeks 2-4. Change in DES-R score will be computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
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Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Lead sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
VA Connecticut Healthcare System
Collaborator
BioXcel Therapeutics Inc
Collaborator
Yale University
Collaborator
RTI International
Collaborator
