Alcohol Use Disorder (AUD)Phase 1NCT06335407
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
A Phase 1 study testing Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg and Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg in people with Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg and Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Have no clinically significant contraindications, in the judgement of the PI/study physician, for study participation (based on self-reported medical history and brief physical examination);
- Have a current diagnosis of Alcohol use disorder (AUD) (mild, moderate, or severe) as determined by MINI-5;
Show all 10Show fewer
- Have a lifetime traumatic event in their lifetime that meets Criterion A for PTSD as determined by screening interview and the MINI-5;
- Have a PCL-5 score > 15 prior to starting the study medication;
- Must have > 1 heavy drinking episodes (>4 standard drink units (SDU) for men; >3 SDU for women) in the last 30 days (assessed by the Timeline Follow Back (TLFB));
- Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for > 6 months)) must be willing to use a medically acceptable and effective birth control method for 1 month before the study and while participating in the study. Medically acceptable methods of contraception that may be used by the participant include abstinence, birth control pills or patches, birth control implants, diaphragm, intrauterine device (IUD), or condoms.
Who cannot join
- 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.
- Recent history of complicated alcohol withdrawal, alcohol withdrawal seizures, or delirium tremens (DTs);
- Score > 4 on Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) at screening;
Show all 14Show fewer
- History of major medical illnesses including liver disease, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the participant to be in the study;
- Clinically significant history of cardiac disease including (a) chronic hypertension (even if adequately controlled by antihypertensive medications); (b) history of syncope or other syncopal attacks; (c) current evidence of orthostatic hypotension (defined as a decrease in systolic BP of 20 mm Hg or decrease in diastolic BP of 10mm Hg within 3 minutes); (d) resting heart rate of <55 beats per minute; (e) systolic blood pressure <110mmHg or diastolic BP <70mmHg; or (f) participants with a QTC interval >440msec (males) or >460msec (females).
- Clinically significant medical conditions including hepatic (ascites, bilirubin >10% above the upper limit of normal [ULN] or liver function tests [LFT] >3 × ULN);
- Renal impairment as measured by BUN/Creatinine;
- Currently taking the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation including sedative/hypnotics, barbiturates, antihistamines, sedative antidepressants (e.g. doxepin, mirtazapine, trazodone), and triptans (e.g., sumatriptan); c) antihypertensive medications; d) alpha-2-adrenergic agonists (clonidine, guanfacine, lofexidine); or adrenergic agents prescribed for other reasons are excluded (prazosin). (Permitted Concomitant Medications: The concomitant medications allowed in the study include non-sedative antidepressants used to treat PTSD);
- History of allergic reactions to dexmedetomidine or known allergy to dexmedetomidine;
- Participation in a clinical trial of a pharmacological agent within 30 days prior to screening;
- Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the study visit schedule or requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Jenelle Newcomb, BA, (203) 932-5711 ext. 12874, jenelle.leblanc@yale.edu
Ismene Petrakis, MD, (203) 932-5711 ext. 12244, ismene.petrakis@yale.edu
About this study
Official title: Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) on Ethanol in Heavy Drinkers With PTSD - Outpatient Study
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.
Read the 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 and/or research staff to assess side effects as well as drinking, PTSD symptoms, cognitive function, memory, sleep and mood.
- Being tested
- Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
- Keywords
- Alcohol Used Disorder (AUD), Post Traumatic Stress Disorder (PTSD), Alcohol Use, Heavy Drinkers, Dexmedetomidine HCl (BXCL501)
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µgDrug
Also called BXCL501 40µg
BXCL 501 40µg will be administered orally, as individual films in the Sub Lingual (SL) space.
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µgDrug
Also called BXCL501 80µg
BXCL 501 80µg will be administered orally, as individual films in the SL space
| Study group | Role | What they receive |
|---|---|---|
| BXCL501 Dose Range 40µg to 160µg | Other | 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. On days 7-28 participants will receive 80µg in the morning and evening. Dose escalation will follow the above schedule based on tolerability assessed by clinician. Receives: Drug: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg; Drug: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From day 1 through day 28
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).
Measured: From day 1 through 28 days
Number and Proportion of Adverse Events
Adverse Events will be monitored and documented through each dose escalation phase after the first dose administration.
Measured: From day 1 through 28 days
Secondary outcomes (10)
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).
Measured: From day 1 through 28 days
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).
Measured: From day 1 through 28 days
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).
Measured: From day 1 through 28 days
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).
Measured: From day 1 through 28 days
Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28.
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).
Measured: From day 1 through 28 days
Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28.
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).
Measured: From day 1 through 28 days
Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28.
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).
Measured: Baseline, Week 2, and Week 4
Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28.
Participants will complete the HVLT-R assessment at baseline, week 2, and week 4. Change in HVLT-R (total recall) will be computed as the difference in measurements taken at Week 2 and 4 from the baseline visit (pre-treatment).
Measured: Baseline, Week 2, and Week 4
Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28.
Participants will complete the ISI assessment at baseline, day 5, day 7, and weeks 2-4. Change in ISI total score will be computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Measured: From day 1 through 28 days
Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28.
Participants will complete the MMSE assessment at baseline, week 2, and week 4. Change in MMSE total score will be computed as the difference in measurements taken at Week 2 and 4 from the baseline visit (pre-treatment).
Measured: Baseline, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 Jul 2025
- Primary completion27 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs, VA Connecticut Healthcare System, BioXcel Therapeutics Inc, Yale University, RTI International
- Responsible party
- Sponsor
- Investigators
- Ismene Petrakis, MD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335407
- Sponsor's protocol ID
- AS210006-A08
- Other IDs
- W81XWH-21-2-0026
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) on Ethanol in Heavy Drinkers With PTSD - Outpatient Study
- ClinicalTrials.gov ID
- NCT06335407
- Acronym / sponsor ID
- AS210006-A08
- Keywords
- Alcohol Used Disorder (AUD), Post Traumatic Stress Disorder (PTSD), Alcohol Use, Heavy Drinkers, Dexmedetomidine HCl (BXCL501)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders AllianceUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs, VA Connecticut Healthcare System, BioXcel Therapeutics Inc, Yale University, RTI International
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or research staff to assess side effects as well as drinking, PTSD symptoms, cognitive function, memory, sleep and mood.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BXCL501 Dose Range 40µg to 160µg | Other | Drug: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Drug: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µgParticipants 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. On days 7-28 participants will receive 80µg in the morning and evening. Dose escalation will follow the above schedule based on tolerability assessed by clinician. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- Have no clinically significant contraindications, in the judgement of the PI/study physician, for study participation (based on self-reported medical history and brief physical examination);
Key exclusion criteria (14 listed)
- 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.
- Recent history of complicated alcohol withdrawal, alcohol withdrawal seizures, or delirium tremens (DTs);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µgAlso: BXCL501 40µgBXCL 501 40µg will be administered orally, as individual films in the Sub Lingual (SL) space. | Drug | BXCL501 Dose Range 40µg to 160µg |
| Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µgAlso: BXCL501 80µgBXCL 501 80µg will be administered orally, as individual films in the SL space | Drug | BXCL501 Dose Range 40µg to 160µg |
Primary outcome
Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.
Time frame: 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).
Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.
Time frame: 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).
Number and Proportion of Adverse Events
Time frame: From day 1 through 28 days
Adverse Events will be monitored and documented through each dose escalation phase after the first dose administration.
10 secondary outcomes
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.
Time frame: From day 1 through 28 days
Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28.
Time frame: From day 1 through 28 days
Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28.
Time frame: From day 1 through 28 days
Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28.
Time frame: From day 1 through 28 days
Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28.
Time frame: From day 1 through 28 days
Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28.
Time frame: From day 1 through 28 days
Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28.
Time frame: Baseline, Week 2, and Week 4
Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28.
Time frame: Baseline, Week 2, and Week 4
Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28.
Time frame: From day 1 through 28 days
Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28.
Time frame: Baseline, Week 2, and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- PASA WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder (AUD)
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ismene Petrakis, MD principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg and Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg in people with Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismene Petrakis, MD ((203) 932-5711 ext. 1-3121, ismene.petrakis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28. (time frame: From day 1 through day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.