Clinical trials: Naloxone
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-Induced Constipation
Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily.
- Trial name
- Naxos (NCT03687268)
- Testing
- Naloxone HCl PR tablets
- Where
- 104 sites in Bulgaria, Czechia and 7 more
- Volunteers
- 1,500 people
- Sponsor
- Develco Pharma Schweiz AG
HIV, Pharmacokinetics
TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.
TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make more copies of itself.
- Trial name
- NCT00828815
- Testing
- TMC125
- Volunteers
- 22 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Anesthesia, Spinal, Elderly
Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients
Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient…
- Trial name
- NCT04673812
- Testing
- Bupivacaine-fentanyl
- Where
- Egypt
- Volunteers
- 92 people
- Sponsor
- Kasr El Aini Hospital
Chronic Pain, Opioid Induced Constipation
Naloxone SR Capsules in Patients With Opioid Induced Constipation
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose.
- Trial name
- NCT00984334
- Testing
- Naloxone SR 5 mg capsules, Naloxone SR 10 mg capsules, Naloxone SR 20mg capsules
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 40 people
- Sponsor
- S.L.A. Pharma AG
Chronic Pain
Effectiveness of Buprenorphine/Naloxone
Long-term use of opioids for chronic pain is a growing health and social problem, mainly because of the risk of dependence. Buprenorphine/naloxone is used as substitution therapy for opioid dependence.
- Trial name
- NCT02882412
- Testing
- observational
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
Opioid-Related Disorders
Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal…
- Trial name
- NCT00134875
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Opioid Dependence
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days.
- Trial name
- NCT02294253
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Drug Interaction, Analgesics
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
- Conditions
- Drug Interaction, Analgesics, Opioid Use Disorder
- Trial name
- NCT04818086
- Testing
- Lemborexant, Buprenorphine-naloxone
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Virginia Commonwealth University
Lactose Intolerants, Lactose Malabsorption
Milk Beta Caseins on Digestive Discomfort, Gastric Emptying
A1 and A2 β-casein are genetic variants of β-casein in cow's milk that differ by a single amino acid at position 67. Digestion of A1 β-casein may result in greater release of beta-casomorphin-7 (BCM-7), an opioid peptide that may…
- Conditions
- Lactose Intolerants, Lactose Malabsorption, Caseins
- Trial name
- Oral Naloxone (NCT07884123)
- Testing
- A1/A2 milk with oral naloxone, A1PF milk with oral naloxone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Purdue University
Opioid Abuse
Buprenorphine Induction and Naloxone Distribution Program-Combined With Warm Hand-Off Referral to Continued Treatment
This study is a collaboration between the University of Utah and Castleview Hospital in Price, Utah. Buprenorphine is a medication approved by the FDA to treat Opioid Use Disorder (OUD).
- Trial name
- BINDeR-TX (NCT06087991)
- Testing
- Implementation of the BINDeR-Tx service model
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Jerry Cochran
Opioid-Related Disorders
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone.
- Trial name
- NCT00000243
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid Use Disorder
Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal…
- Trial name
- NCT04234191
- Testing
- Buprenorphine/naloxone, Hydromorphone
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- University of British Columbia
Healthy
Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity
In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to…
- Trial name
- NCT00947284
- Testing
- nalbuphine plus naloxone, nalbuphine plus saline, naloxone plus saline
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Hyperalgesia
Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery.
- Trial name
- NCT03066739
- Testing
- Remifentanil, Remifentanil +ultra-low dose naloxone
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, Irvine
Opioid-Related Disorders
Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.
- Trial name
- NCT00000344
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid Overdose
Developing and Testing the Opioid Rapid Response System
This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.
- Trial name
- NCT04589676
- Testing
- Naloxone training
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Pain, Nausea
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting.
- Conditions
- Pain, Nausea, Pruritus
- Trial name
- NCT00330343
- Testing
- naloxone
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Johns Hopkins University
Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine. PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in…
- Trial name
- NCT00020605
- Testing
- naloxone hydrochloride
- Where
- United States
- Sponsor
- Dana-Farber Cancer Institute
Cancer, Pain
A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain
The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone alone in patient's specific type of "chronic cancer pain".
- Conditions
- Cancer, Pain, Constipation
- Trial name
- NCT00513656
- Testing
- Oxycodone, Oxycodone/Naloxone
- Where
- United Kingdom
- Volunteers
- 230 people
- Sponsor
- Mundipharma Research GmbH & Co KG