Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335407
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-02-26
Brief Title:
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride HCl BXCL501 - Outpatient Study
Sponsor:
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Organization:
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Study Overview
Official Title:
Effect of Sublingual Formulation of Dexmedetomidine HCl BXCL501 on Ethanol in Heavy Drinkers With PTSD - Outpatient Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials
Detailed Description:
BXCL501 is a sublingual film containing dexmedetomidine Dexmedetomidine is an alpha-2 adrenergic receptor agonist and has higher intrinsic activity and is more potent in vitro than either clonidine or lofexidine The drug has a high free brain to free plasma ratio after dosing in rats that persists after plasma concentrations are cleared Dexmedetomidine does not depress respiratory function It is not predicted to have abuse potential BXCL501 will bypass 1st pass metabolism and produce fewer problems in participants with compromised liver function
This laboratory study is a phase 1b open label single arm safety study which is a follow-up to the Effect of Sublingual formulation of Dexmedetomidine HCl BXCL501 on Ethanol in Heavy Drinkers with PTSD - Alcohol Interaction Study Previously conducted Participants will be heavy drinkers with comorbid PTSD or no diagnosis of PTSD but have experienced at least one qualifying Criterion A traumatic event For the study at least 10 completers will participate in an outpatient study Participants will receive BXCL501 for 28 days Participants will receive 40µg on days 1-2 On days 3 and 4 participants will receive 40µg twice per day On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening If dosing is tolerated per clinical judgement participants will begin to receive 80µg twice per day on days 7-28 Participants will be seen in the clinic on days 1 5 - 2 days and during weeks 1 2 3 and 4 with the study nurse andor research staff to assess side effects as well as drinking PTSD symptoms cognitive function memory sleep and mood
This laboratory study is a phase 1b open label single arm safety study which is a follow-up to the Effect of Sublingual formulation of Dexmedetomidine HCl BXCL501 on Ethanol in Heavy Drinkers with PTSD - Alcohol Interaction Study Previously conducted Participants will be heavy drinkers with comorbid PTSD or no diagnosis of PTSD but have experienced at least one qualifying Criterion A traumatic event For the study at least 10 completers will participate in an outpatient study Participants will receive BXCL501 for 28 days Participants will receive 40µg on days 1-2 On days 3 and 4 participants will receive 40µg twice per day On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening If dosing is tolerated per clinical judgement participants will begin to receive 80µg twice per day on days 7-28 Participants will be seen in the clinic on days 1 5 - 2 days and during weeks 1 2 3 and 4 with the study nurse andor research staff to assess side effects as well as drinking PTSD symptoms cognitive function memory sleep and mood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-21-2-0026 | OTHER_GRANT | DoDCongressionally Directed Medical Research Program | None |