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RESTLESSNESS and Oxycodone

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RESTLESSNESS Symptoms and Causes

For most adults, moderate alcohol use is probably not harmful. However, about 18 million adult Americans have an alcohol use disorder (AUD). This means that their drinking causes distress and harm. It includes alcoholism and alcohol abuse.

Alcoholism, or alcohol dependence, is a disease that causes

  • Craving - a strong need to drink
  • Loss of control - not being able to stop drinking once you've started
  • Physical dependence - withdrawal symptoms
  • Tolerance - the need to drink more alcohol to feel the same effect

With alcohol abuse, you are not physically dependent, but you still have a serious problem. The drinking may cause problems at home, work, or school. It may cause you to put yourself in dangerous situations, or lead to legal or social problems.

Another common problem is binge drinking. It is drinking about five or more drinks in two hours for men. For women, it is about four or more drinks in two hours.

Too much alcohol is dangerous. Heavy drinking can increase the risk of certain cancers. It can cause damage to the liver, brain, and other organs. Drinking during pregnancy can harm your baby. Alcohol also increases the risk of death from car crashes, injuries, homicide, and suicide.

You may have an AUD if you can answer yes to two or more of these questions:

In the past year, have you

  • Ended up drinking more or for a longer time than you had planned to?
  • Wanted to cut down or stop drinking, or tried to, but couldn't?
  • Spent a lot of your time drinking, or recovering from drinking?
  • Felt a strong need to drink?
  • Found that drinking - or being sick from drinking - often interfered with your family life, job, or school?
  • Kept drinking even though it was causing trouble with your family or friends?
  • Given up or cut back on activities that you enjoyed just so you could drink?
  • Gotten into dangerous situations while drinking or after drinking? Some examples are driving drunk and having unsafe sex.
  • Kept drinking even though it was making you feel depressed or anxious? Or when it was adding to another health problem?
  • Had to drink more and more to feel the effects of the alcohol?
  • Had withdrawal symptoms when the alcohol was wearing off? They include trouble sleeping, shakiness, irritability, anxiety, depression, Restlessness, nausea, and sweating. In severe cases, you could have a fever, seizures, or hallucinations.

If you have any of these symptoms, your drinking may already be a cause for concern. The more symptoms you have, the more serious the problem is. If you think you might have an AUD, see your health care provider for an evaluation. Your provider can help make a treatment plan, prescribe medicines, and if needed, give you treatment referrals.

NIH: National Institute on Alcohol Abuse and Alcoholism

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RESTLESSNESS Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Rank Status Study
1 Recruiting Abuse Liability of Controlled-Release Oxycodone Formulations
Condition: Substance-Related Disorders
Interventions: Drug: Apo-Oxycodone CR®;   Drug: OxyNEO®;   Drug: OxyContin®;   Drug: Placebo
Outcome Measures: Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration;   Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration;   Pupil Diameter;   Cmax;   Profile of Mood States (POMS);   Psychomotor Performance;   Visual Analogue Scale for "Any Drug Effects";   Visual Analogue Scale for "Good Effects";   Visual Analogue Scale for "Bad Effects";   Visual Analogue Scale for "Feel Sick";   Visual Analogue Scale for "Nausea";   Visual Analogue Scale for "Sleepy";   Visual Analogue Scale for "Dizzy";   Sedation;   Euphoria;   Dysphoric Changes;   Psychotomimetic Changes;   Somatic Disturbances;   Sensory Disturbances;   Tmax
2 Recruiting Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
Condition: Arthroplasty, Replacement, Hip
Interventions: Drug: Standard Care morphine hydrochloride;   Drug: Oxycodone
Outcome Measures: Composite score of complications;   Number of opioid boluses in the post-intervention surveillance room;   Time to obtain a VAS score < 30/100 (from the first administration; minutes);   Length of stay in the post-intervention surveillance room (minutes);   Total dose of opioids during the first 24 hours (mg);   Total number of opioid requestions (patient controlled analgesia = PCA);   Total number of opioid requestions accepted / refused (PCA);   Ramsay score;   Presence / absence of an overdose of morphine/Oxycodone (Ramsay score > 4);   Presence / absence of an overdose of morphine/Oxycodone (Ramsay score> 4);   Presence/absence of complications;   Patient satisfaction, VAS scale;   Pain while at rest at while moving (Visual Analog Scale);   DN4 score;   Length of hospital stay (hours)
3 Recruiting Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Condition: Postcraniotomy Pain
Interventions: Drug: Oxycodone;   Drug: Codeine
Outcome Measures: To determine the difference in the mean pain VAS scores in the Oxycodone and codeine groups at 24hr.;   To look at the incidence of adverse events in the Oxycodone and codeine groups.
4 Recruiting A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients
Condition: Cancer
Intervention: Drug: Oxycodone and naloxone
Outcome Measures: Assess reduction of pain intensity;   Efficacy parameters including long term safety and efficacy
5 Not yet recruiting Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
Condition: Pediatric Surgical Patient
Intervention: Drug: oral Oxycodone
Outcome Measure: Oxycodone, oxymorphone, noroxymorphone and norOxycodone serum levels
6 Recruiting Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Condition: Pain
Intervention: Drug: Oxycodone HCl controlled-release tablets
Outcome Measures: The number of participants with adverse events as a measure of safety.;   To characterize the efficacy and provide additional pharmacokinetics (PK) data of Oxycodone hydrochloride controlled-release tablets
7 Unknown  Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain
Condition: Low Back Pain
Interventions: Drug: etoricoxib;   Drug: Oxycodone
Outcome Measures: Proportion of patients achieving a > 30% reduction in avg daily pain intensity at treatment week 4 (Visit 4).;   Proportion of patients achieving a > 50% reduction in avg daily pain intensity at treatment week 5 (visit 4).
8 Recruiting Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects
Condition: Pain
Intervention: Drug: Oxycodone
Outcome Measures: Cmax of Oxycodone Oral Solution.;   Safety of Oxycodone Oral Solution in Pediatric Patients
9 Not yet recruiting Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
Condition: Healthy
Intervention: Drug: Oxycodone
Outcome Measures: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)];   Maximum Observed Plasma Concentration (Cmax);   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast);   Concentration at time 24 hours (C24);   Time to Reach Maximum Observed Plasma Concentration (Tmax);   Plasma Decay Half-Life (t1/2)
10 Unknown  A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
Condition: Post Tonsillectomy Pain
Interventions: Drug: 0,1 mg/kg of Oxycodone;   Drug: Morphine 0,1 mg/kg;   Drug: Dexamethasone 0,5 mg/kg;   Drug: NaCl 0,9%
Outcome Measures: The difference of needed rescue pain medication post operatively;   differences in adverse effects
11 Recruiting An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders
Condition: Spinal Disorders Related Pain
Intervention: Drug: Oxycodone/Naloxone
Outcome Measures: 24hr pain intensity score (Numeric rating score: 0 -10);   EuroQol-5 Dimension(EQ-5D);   Overall satisfaction of Physicians and subjects
12 Recruiting Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
Condition: Pain, Postoperative
Interventions: Drug: Buprenorphine;   Drug: Oxycodone
Outcome Measures: Mobilization measured daily using Cumulated Ambulation Score.;   Pain intensity measured daily on a verbal rating scale;   Adverse effects;   Opioid consumption.;   Length of stay in Hospital
13 Not yet recruiting A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery
Conditions: Postoperative Pain;   Postoperative Nausea and Vomiting
Interventions: Drug: Targinact;   Drug: Oxycodone;   Procedure: Laparoscopic segmental colectomy
Outcome Measures: Prevalence of postoperative gut dysfunction;   Pain control;   Oral analgesia use;   Pain scores
14 Recruiting Targin Cancer Pain
Conditions: Cancer;   Pain
Interventions: Drug: Oxycodone/Naloxone;   Drug: Oxycodone
Outcome Measures: BFI-Bowel Function Index;   BPI-Brief Pain Index
15 Not yet recruiting A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Condition: Healthy
Interventions: Drug: GL2907;   Drug: Oxycontine CR 10mg
Outcome Measures: Cmax,ss;   AUCτ;   Tmax;   t1/2;   Vz/f;   CL/F;   Cmin,ss;   Cave,ss;   degree og fluctuation;   swing;   R
16 Recruiting Targin for Non-cancer Pain
Condition: Non Cancer Pain
Intervention: Drug: Oxycodone/naloxone prolonged release tablets
Outcome Measures: Bowel function index(BFI) 12 Weeks;   Modified BPI-SF-Average Pain over the last 24 hours
17 Recruiting RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.
Conditions: Cancer;   Cancer Pain
Interventions: Drug: Morphine;   Drug: Fentanyl;   Drug: Buprenorphine;   Drug: Oxycodone
Outcome Measures: Proportion of Non-Responder (NR) patients;   Proportion of full-responder
18 Recruiting Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
Conditions: Opioid Abuse;   Opioid Dependence
Interventions: Drug: MN-166 (formerly AV411);   Drug: placebo
Outcome Measures: pain intensity;   positive subjective effects to Oxycodone
19 Recruiting Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Condition: Opioid Abuse
Intervention: Drug: pioglitazone
Outcome Measures: Subjective ratings of drug, mood, and physiological effects;   Analgesic responses using the cold pressor test
20 Recruiting Abuse Potential Study of PF-00345439
Condition: Opioid Users
Interventions: Drug: Capsule;   Drug: PF-00345439;   Drug: Oxycodone
Outcome Measures: Drug Liking: Peak Effect (Emax);   High: Peak Effect (Emax);   Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours;   High: Area Under Effect Curve (AUE) From 0-2 Hours;   Take Drug Again Effect at 24 Hours;   Overall Drug Liking;   Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour;   Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour;   Chewing Duration;   Taste: Subjective Experience from Chewing;   Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-2 Hours;   Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-3 Hours;   Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-12 Hours;   Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours;   Pupillometry: Area Under Effect Curve (AUE) From 0-3 Hours;   Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours;   High: Area Under Effect Curve (AUE) From 0-1 Hour;   High: Area Under Effect Curve (AUE) From 0-3 Hours;   High: Area Under Effect Curve (AUE) From 0-12 Hours;   Good Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour;   Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours;   Good Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours;   Good Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours;   Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour;   Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours;   Bad Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours;   Bad Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours;   Feeling Sick: Area Under Effect Curve (AUE) From 0-1 Hour;   Feeling Sick: Area Under Effect Curve (AUE) From 0-2 Hours;   Feeling Sick: Area Under Effect Curve (AUE) From 0-3 Hours;   Feeling Sick: Area Under Effect Curve (AUE) From 0-12 Hours;   Nausea: Area Under Effect Curve (AUE) From 0-1 Hour;   Nausea: Area Under Effect Curve (AUE) From 0-2 Hours;   Nausea: Area Under Effect Curve (AUE) From 0-3 Hours;   Nausea: Area Under Effect Curve (AUE) From 0-12 Hours;   Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour;   Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours;   Sleepy: Area Under Effect Curve (AUE) From 0-3 Hours;   Sleepy: Area Under Effect Curve (AUE) From 0-12 Hour;   Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour;   Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours;   Dizzy: Area Under Effect Curve (AUE) From 0-3 Hours;   Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours;   Bad Effects: Peak Effect (Emax);   Nausea: Peak Effect (Emax);   Feel Sick: Peak Effect (Emax);   Sleepy: Peak Effect (Emax);   Dizzy: Peak Effect (Emax);   Pupillometry: Peak Effect (Emax);   Good Drug Effects: Peak Effect (Emax);   Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour;   Drug Liking: Area Under Effect Curve (AUE) From 0-3 Hours;   Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours;   Drug Liking: Time to Maximum (Peak) Effect (TEmax);   High: Time to Maximum (Peak) Effect (TEmax);   Any Drug Effects: Time to Maximum (Peak) Effect (TEmax);   Good Drug Effects: Time to Maximum (Peak) Effect (TEmax);   Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax);   Feel Sick: Time to Maximum (Peak) Effect (TEmax);   Nausea: Time to Maximum (Peak) Effect (TEmax);   Sleepy: Time to Maximum (Peak) Effect (TEmax);   Dizzy: Time to Maximum (Peak) Effect (TEmax);   Pupillometry: Time to Maximum (Peak) Effect (TEmax);   Any Drug Effects: Peak Effect (Emax);   Texture: Subjective Experience from Chewing;   Maximum Observed Plasma Concentration (Cmax);   Time to Reach Maximum Observed Plasma Concentration (Tmax);   Area under the curve (AUC);   Systemic Clearance (CL);   volume of distribution (Vd);   Half-Life (t1/2)