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.
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