Clinical Trial Search

Primary: Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications) — 10; 6; 7 percentage of PIVC sites

Primary: Change in Serum β-hydroxybutyrate (BHB) — 40.717 µM — p=<0.001

Primary: Change in Inflammatory Lesion Count From Baseline to Week 12 — -18.1; -13.5 Lesions — p=0.043

Primary: Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) — 10.0; 23.3; 20.0; 73.3 Percentage of participants

Primary: Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment — 4 Participants

Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -8.6; -8.0; -9.5; -10.6 score on a scale — p=>0.05

Primary: Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling. — -2 score on a scale

Primary: Percentage of Participants That Maintain MEC — 10 Participants

Primary: Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment — 13.9; 13.8; -0.6; -0.4 score on a scale — p=0.6909

Primary: Latency to Initiate Ad-lib Smoking Session — 31.55; 30.31 minutes

Primary: Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours — 2.4; 3.4 score on a scale

Primary: Change in General Paranoid Ideation for Active vs. Sham Simulation — 1.60; .73 score on a scale

Primary: Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12 — -0.10; -0.15; -0.53 Log(mg/g) — p=0.7953

Primary: MGI-Modified Gingival Index — 0.30; -0.13 score on a scale

Primary: Parts 1, 2, 4, and 5: Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) — 1; 1; 1; 2 Participants