Registered outcomes13

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

1 to 13 of 13

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).
Secondary	Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28.	Baseline, Week 2, and Week 4	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).
Secondary	Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28.	From day 1 through 28 days	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).
Secondary	Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28.	Baseline, Week 2, and Week 4	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).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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