Phase 2 N=51 Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse
Opioid Dependence
Primary: Number of Participants Retained in Study — 18 participants
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Phase 2 N=27 Prescription Opioid Effects in Abusers Versus Non-Abusers
Opioid-Related Disorders · Substance-Related Disorders
Primary: Breakpoint — 25; 400; 1400; 850 Mouse Clicks
Phase 4 N=60 Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users
Abuse Potential
Primary: Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax). — 54.30; 90.85; 72.53; 76.05 Score on a 100 mm scale — p=<0.0001
Phase 2 N=12 A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Opioid Abuse · Opioid Dependence
Primary: Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) — 12.6; 1.3 units on a scale
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 2 N=12 Oxytocin Treatment of Opioid Dependence
Opioid Dependence · Opioid Withdrawal
Primary: Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive — 4.2; 3.4 Average COWS score * hours
N/A N=78 Stress, Distress Intolerance, and Drug Dependence
Substance Dependence
Primary: Percentage of Positive Toxicology Swabs for Illicit Substances — 81.3; 79.1; 86.2; 82.3 percentage of positive toxicology screen
Phase 2 N=16 A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.
Opioid Use Disorder
Primary: Positive Subjective Drug Effects (i.e., Drug "Liking"). — 52.1; 57.5; 71.8; 71.5 units on a scale — p=.0001
Phase 4 N=12 A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Chronic Pain
Primary: 3 Scores on the Addiction Research Center Inventory (ARCI) — 7.6; 5.4; 5.2; 3.3 scores on a scale
N/A N=190 Opioid Prescribing After Cesarean Delivery
Surgery · Opioid Use
Primary: Unused Opioids — 5; 10 oxycodone 5mg tablets
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=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
Phase 4 N=19 Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Low Back Pain
Primary: Analgesia — 36.3; 71.8 units on a VAS scale — p=0.097
Phase 1 N=27 Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder
Opioid Abuse · Opioid Dependence · Opioid-Related Disorders
Primary: Change in Subjective Response to Oxycodone Measured With 100 Millimeter Visual Analog Scale — -13.81; -9.67 units on a scale
N/A N=1,731 Opioid Use Disorder in the Emergency Department: CTN 0069
Opioid Use Disorder
Primary: Implementation (Considered the Primary Outcome) — 2; 53 Participants — p=<0.001
N/A N=300 Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
Opioid Dependence
Primary: Initiation of Treatment for Opioid Dependence — 85; 74; 63; 75 Participants
N/A N=9 Aprepitant Effects on Oxycodone Response
Narcotic Abuse
Primary: Abuse Liability Proxy — 0.197; 0.483; 0.159; 7.678 units on a scale (points 0-100) — p=<.05
N/A N=211 TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051
Opioid Use Disorder
Primary: Days of Opioid Use — 6.8 days
N/A N=213 Single Session Class to Reduce Opioid Use in Chronic Pain
Chronic Pain
Primary: Opioid Use — -6.7; -8.0 MME — p=.89
N/A N=329 Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Opiate Addiction
Primary: Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) — 4.99; 5.67; 3.71 Mean Number of Outpatient…
Phase 2 N=47 A Multiple Dose Opioid Challenge Study
Moderate or Severe Opioid Use Disorder
Primary: Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w…
N/A N=119 Stress Response in Opioid Use Disorder
Opioid-use Disorder
Primary: Change in Negative Affect — 1.67; 1.25; 3.60 scores on a scale
N/A N=133 5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
Opioid Withdrawal · Physical Dependence
Primary: Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal) — 3.6; 3.6 units on a scale — p=0.87
Phase 2 N=28 Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
Opioid Abuse · Opioid Dependence
Primary: Drug Self-administration Breakpoint — 347; 363; 1472; 43 Clicks on a computer mouse
Phase 3 N=49 Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder
Opioid-use Disorder
Primary: Proportion of Patients Successfully Inducted to Receive Naltrexone Injection — 12; 7 Participants
N/A N=115 Opioid Treatment and Recovery Through a Safe Pain Management Program
Depression · Opioid Use · Chronic Pain
Primary: Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg — 0.209; 0.417; 0.185; 0.364 odds of prescription high dose — p=0.956
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
N/A N=93 Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function
Chronic Pain
Primary: Mean of the Change in Morphine Dosage (in mg) Required to Achieve 25% Reduction in Thermal Evoked Pain Responses Relative to Baseline (Pre-intervention) Placebo…
Phase 2 N=39 Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
Opioid Use Disorder
Primary: Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question "Do You Like the Drug?"…
N/A N=1,542 Emergency Department Outcomes for Patients With Opioid Use Disorder
Opioid-use Disorder
Primary: Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP) — 39.40 Percentage of participants