Phase 1 N=31 Staccato Alprazolam Abuse Liability
Abuse Liability of Staccato Alprazolam
Primary: Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again" — 0; 1.714; 2.143; 2.286 units on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=49 Staccato Alprazolam in Panic Attack
Treatment of Induced Panic Attack
Primary: Number of Participants With Doxapram-induced Panic Attack — 14; 9 Participants — p=0.200
Phase 2 N=5 Staccato Alprazolam and Photoparoxysmal Response
Epilepsy
Primary: Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) — -0.2; -4.4; -5.2; -4.8 Number of frequency steps
Phase 2 N=156 Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Epilepsy
Primary: Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours — 62.5; 42.5; 65.8; 65.8…
Phase 1 N=36 A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Alzheimer's Disease · Huntington's Disease
Primary: Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) — 57.8; 78.6; 82.2; 57.2 mm — p=<0.0001
Phase 1 N=96 A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Recreational Drug Use · Prescription Drug Abuse (Not Dependent)
Primary: Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores — 53.0; 85.4; 68.6; 73.3 millimeter (mm)
Phase 2 N=129 Staccato Loxapine in Agitation (Proof of Concept)
Schizophrenia
Primary: PANSS-EC Change From Baseline — -4.98; -6.71; -8.56 PANSS units — p=0.0880
Phase 1 N=50 Staccato Loxapine Single Dose PK
Schizophrenia
Primary: Tmax — 12.6; 2.15; 2.87; 2.13 minutes
Phase 3 N=344 Staccato Loxapine in Agitated Patients With Schizophrenia
Patients With Schizophrenia and Acute Agitation
Primary: Change in PANSS-EC From Baseline — -5.5; -8.1; -8.6 units on a scale — p=0.0004
Phase 3 N=17 Abuse Liability of Suboxone Versus Subutex
Opioid-related Disorders
Primary: Drug's Breakpoint — 1200; 10; 1100; 1200 number of clicks on a mouse
Phase 2 N=49 Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Opioid Abuse
Primary: Drug Liking at .5 Hours — 66.0; 74.7; 47.7; 40.9 score on a scale
Phase 1 N=32 Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
Healthy
Primary: Cmax - Maximum Observed Concentration — 24.33; 23.62 ng/mL
Phase 3 N=314 Staccato Loxapine in Agitated Patients With Bipolar Disorder
Bipolar I Disorder
Primary: Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo — -4.9; -8.1; -9.0 units on a scale — p=<0.0001
Phase 4 N=63 Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users
Abuse Potential
Primary: Drug Liking Visual Analog Scale (VAS) — 56.4; 84.9; 59.6; 64.6 score on a scale
Phase 1 N=48 Staccato Loxapine Thorough QT/QTc Study
Thorough QT/QTc Study
Primary: Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo — 5.418 mseconds
Phase 1 N=36 Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
Healthy
Primary: Cmax - Maximum Observed Concentration — 28.79; 28.95 ng/mL
Phase 2 N=30 Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Opioid Abuse
Primary: Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) — 11.7; 14.7 score on a scale
Phase 1 N=45 A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
Healthy
Primary: Drug Liking: Peak Effect (Emax) — 50.9; 60.5; 51.3; 92.8 mm — p=0.0001
Phase 2 N=168 Staccato Loxapine in Migraine (in Clinic)
Migraine
Primary: Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours — 20; 29; 34; 33 participants — p=0.0212
Phase 4 N=51 An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users
Abuse Potential
Primary: Drug Liking "at This Moment" Visual Analog Scale (VAS) — 54.1; 83.8; 58.9; 58.4 score on a scale
Phase 2 N=366 Staccato Loxapine in Migraine (Out Patient)
Migraine Headache
Primary: Pain-Relief at 2 Hours Post-treatment — 56; 65; 66 Participants
Phase 1 N=75 A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
Healthy
Primary: Drug Liking: Peak Effect (Emax) — 51.6; 70.1; 85.5; 59.3 mm — p=<0.0001
Phase 1 N=12 A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Pain · Nausea · Vomiting
Primary: Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase — 85.0; 42.0; 75.5; 94.0 units on a scale
Phase 2 N=44 Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
Opioid-Related Disorders
Primary: Emax - Maximum Drug Liking — 54.5; 75.0; 72.1; 75.6 score on a scale
Phase 4 N=18 Opiates and Benzodiazepines on Driving
Driving Behavior
Primary: SDLP — 35.2; 49.8; 50.0; 33.5 centimeters
Phase 3 N=108 Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
Generalized Anxiety Disorder
Primary: Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free — 20; 10…
Phase 2 N=75 Staccato Prochlorperazine in Migraine (in Clinic)
Migraine Headache, With or Without Aura
Primary: Headache Pain Relief at 2 hr Post-dose by 2-point Definition — 6; 11; 13 Participants
Phase 2 N=19 Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
Benzodiazepine Dependence · Opioid Dependence
Primary: Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back — 4.0; 2.3 milligrams/day
N/A N=170 Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention
Taking Benzodiazepines for Any Reason for 3 Months · Benzodiazepine Dependence
Primary: 25% Reduction in Benzodiazepine Use — 14; 6 Participants
Phase 1 N=80 Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Nondependent Opioid Abuse, Episodic
Primary: Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours — 88.3; 100.3; 124.7 hrs*mm — p=<0.0001