Trial · NCT06335407

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

NCT06335407, Phase 1, Recruiting, Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study. Trials, record NCT06335407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06335407

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
NCT number: NCT06335407
Status: Recruiting
Phases: Phase 1
Enrollment: 10 participants, estimated
Lead sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Conditions: Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Interventions: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
First posted: 2024-03-28
Last updated: 2026-09-21

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.	From day 1 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).
Primary	Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	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).
Primary	Number and Proportion of Adverse Events	From day 1 through 28 days	Adverse Events will be monitored and documented through each dose escalation phase after the first dose administration.
Secondary	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.	From day 1 through 28 days	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).
Secondary	Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	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).
Secondary	Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	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).
Secondary	Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	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).
Secondary	Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	Participants will complete the PHQ-9 assessment at baseline, day 5, day 7, and weeks 2-4. Change in PHQ-9 score will be computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Secondary	Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	Participants will complete the PANAS assessment at baseline, day 5, day 7, and weeks 2-4. Change in PANAS scores (both negative and positive affective scales) will be computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Secondary	Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28.	Baseline, Week 2, and Week 4	Participants will complete the VR-12 assessment at baseline, week 2, and weeks 4. Change in VR-12 scores (both physical and mental scales) will be computed as the difference in measurements taken at week 2 and week 4 from the baseline visit (pre-treatment).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Learning	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06335407

GET https://conductscience.org/api/trials/v1/NCT06335407/registered

API reference For AI assistants