160
Participants
Start Date
February 28, 2023
Primary Completion Date
June 30, 2025
Study Completion Date
November 30, 2025
BXCL501 (180 micrograms)
Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design.
BXCL501 (240 micrograms)
Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design.
Placebo
Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design.
Lofexidine (Positive Control)
Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design.
New York State Psychiatric Institute, New York
Yale University, New Haven
Clinilabs, Eatontown
CenExel HRI, Marlton
Collaborators (2)
BioXcel Therapeutics Inc
INDUSTRY
Yale University
OTHER
Clinilabs, Inc.
OTHER
National Institute on Drug Abuse (NIDA)
NIH
CenExel HRI
UNKNOWN
New York State Psychiatric Institute
OTHER