Clinical trials: Opioid Abuse
Pain, Nausea
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
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo…
- Conditions
- Pain, Nausea, Vomiting
- Trial name
- NCT02712554
- Testing
- CL-108, M366
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Charleston Laboratories, Inc
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
Opioid Use Disorder, Opioid Use
Novel Induction to Buprenorphine/Naloxone
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction.
- Conditions
- Opioid Use Disorder, Opioid Use, Opioid Abuse, Opioid Misuse
- Trial name
- NCT05644587
- Testing
- buprenorphine/naloxone
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Bicycle Health
Opioid-Related Disorders, Pain, Acute
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of a new and a marketed tablet formulation under fasted and fed conditions in healthy adults.
- Conditions
- Opioid-Related Disorders, Pain, Acute, Pain, Postoperative
- Trial name
- NCT03137017
- Testing
- Norco 5Mg-325Mg Tablet, GRT7014 - Abuse Deterrent Tablet
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
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
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
Opioid-Related Disorders
Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in…
- Trial name
- NCT00734461
- Testing
- oxycodone and naltrexone
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Pain Therapeutics
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.
Opioid Use Disorder
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
- Trial name
- NCT02537574
- Testing
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- Where
- 20 sites in United States
- Volunteers
- 380 people
- Sponsor
- Alkermes, Inc.
Chronic Disease, Pain
Conversion to Embeda With Rescue Trial
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be…
- Trial name
- ConvERT (NCT01179191)
- Testing
- morphine sulfate and naltrexone hydrochloride (EMBEDA)
- Where
- 166 sites in United States
- Volunteers
- 684 people
- Sponsor
- Pfizer
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
- Trial name
- NCT01746901
- Testing
- intact ALO-02 60 mg/7.2 mg, crushed ALO-02 60 mg/7.2 mg, crushed oxycodone IR 60 mg
- Where
- Canada
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
- Trial name
- NCT02218021
- Testing
- Samidorphan, Oxycodone
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
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
Healthy
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
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
- Trial name
- NCT01775189
- Testing
- crushed ALO-02 30 mg/3.6 mg, crushed oxycodone IR 30 mg
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid-Related Disorders, Opiate Addiction
Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B
The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667197
- Testing
- Algorithm to determine overdose from opioid abuse
- Volunteers
- 2,701 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Substance Use Disorders, Opioid Use Disorder
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD)…
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder
- Trial name
- EDITOR (NCT06434818)
- Testing
- EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance), CBOT with olfactory stimulants & OFC tasks
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Evon Medics LLC
Narcotic Abuse, Opioid-related Disorders
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male…
- Conditions
- Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
- Trial name
- NCT01595867
- Testing
- EMBEDA - morphine sulfate/ naltrexone hydrochloride, morphine sulfate CR crushed.
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid Dependence
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4.
- Trial name
- NCT02038790
- Testing
- Suboxone Sublingual Film, Zubsolv sublingual tablets
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indivior Inc.
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
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