Clinical trials: Opioid Abuse
Drug Abuse
A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users
The purpose of this study is to assess the relative abuse potential of the hydrocodone bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
- Trial name
- NCT01596673
- Testing
- 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)
- Where
- 2 sites in United States, Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Cephalon
Analgesia, Acute Pain
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed…
- Conditions
- Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse
- Trial name
- NCT01530542
- Testing
- oxycodone hydrochloride, marketed oxycodone hydrochloride
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Nondependent Opioid Abuse, Episodic
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to…
- Trial name
- NCT01380093
- Testing
- MS Contin (morphine sulfate, controlled release), EMBEDA (morphine sulfate / naltrexone hydrochloride)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid Related Disorders, Opiate Addiction
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could…
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920775
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 360,000 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid-Related Disorders, Opiate Dependence
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00725608
- Testing
- buprenorphine/naloxone
- Where
- Austria
- Volunteers
- 339 people
- Sponsor
- Indivior Inc.
Healthy
A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users
The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.
- Trial name
- NCT01825447
- Testing
- Oxycodone + Naltrexone, Oxycodone
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support…
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02897414
- Testing
- Surveillance of state medical examiner databases
- Volunteers
- 13,015 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid-Related Disorders, Opiate Addiction
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
The purpose of this study is to evaluate the effect on pain intensity (PI) of structured discontinuation of long-term opioid analgesic therapy compared to continuation of opioid therapy in Suboptimal and Optimal Responders to…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02741076
- Testing
- Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
- Where
- 61 sites in United States
- Volunteers
- 44 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-use Disorder, Substance Use Disorders
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other…
- Trial name
- NCT04197921
- Testing
- Exablate Model 4000 Type 2.0/2.1
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- InSightec
Cocaine Abuse
ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
- Trial name
- NCT01366001
- Testing
- ALKS 33-BUP, ALKS 33
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Alkermes, Inc.
Opioid Abuse
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent…
- Trial name
- NCT01030406
- Testing
- 40/0mg taken first, 80/0mg taken first, 40/240mg taken first
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Acura Pharmaceuticals Inc.
Substance Abuse
A Clinical Decision Support Tool for Electronic Health Records
For behavioral health clinicians who are interested in getting tailored treatment and level of care recommendations, "BH-CDS" is a desktop/tablet web-based application that provides clinicians with data and a rationale for better…
- Trial name
- BHCDS (NCT02697643)
- Testing
- BHCDS-based recommendations, Non-tailored recommendations
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Inflexxion, Inc.
Opioid Addiction, Opioid Abuse, Continuous Use
Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth.
- Conditions
- Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use, Opioid-Related Disorders
- Trial name
- NCT03394911
- Testing
- 250mg healthy adult male facial skin surface lipid liquid pheromone
- Volunteers
- 500 people
- Sponsor
- Bubba Nicholson
Nalbuphine, Opioid Abuse
Oral Abuse Potential Study of Nalbuphine
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients).
- Trial name
- NCT04018664
- Testing
- Nalbuphine HCl solution
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Substance Abuse
A Comparison of How Likely it is That Different Tablets of Oxycodone Will be Broken up and Snorted by Adults Who Sometimes Take Drugs for Pleasure
The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call.
- Trial name
- NCT03765346
- Testing
- Oxycodone IR ADF, Oxycodone API powder
- Where
- Canada
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Opioid-Related Disorders, Opiate Addiction
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02678507)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Volunteers
- 800 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-Related Disorders, Opiate Addiction
Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review
To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667210
- Testing
- Medical Record Review
- Volunteers
- 590 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid Related Disorders, Opiate Addiction
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920762
- Testing
- on-interventional study - retrospective database review
- Volunteers
- 5,575,834 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Opioid-Related Disorders, Opiate Addiction
A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02660606)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Member Companies of the Opioid PMR Consortium