Clinical trials: Opioid
Moderate or Severe Opioid Use Disorder
A Multiple Dose Opioid Challenge Study
Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use…
- Trial name
- NCT02611752
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Braeburn Pharmaceuticals
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
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
Postoperative Pain, Hernia
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Conditions
- Postoperative Pain, Hernia, Surgery
- Trial name
- NCT00974350
- Testing
- SABER-Bupivacaine
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 124 people
- Sponsor
- Durect
Knee Osteoarthritis
An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.
- Trial name
- NCT03661996
- Testing
- CNTX-4975-05, Lidocaine without epinephrine, ElastoGel
- Where
- 28 sites in United States
- Volunteers
- 854 people
- Sponsor
- Centrexion Therapeutics
Opioid Use Disorder, Opioid-related Disorders
Open-Label Treatment Extension Study
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
- Trial name
- NCT02896296
- Testing
- RBP-6000
- Where
- 29 sites in United States
- Volunteers
- 208 people
- Sponsor
- Indivior Inc.
Osteoarthritis
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip…
- Trial name
- NCT00312572
- Testing
- Buprenorphine transdermal patch
- Where
- 36 sites in United States
- Volunteers
- 204 people
- Sponsor
- Purdue Pharma LP
Respiratory Depression
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users.
- Trial name
- NCT03996694
- Testing
- Belbuca 300 µg, Belbuca 600 µg, Belbuca 900 µg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- BioDelivery Sciences International
Pain
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean…
- Trial name
- NCT01165281
- Testing
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- Where
- 52 sites in Japan, South Korea
- Volunteers
- 343 people
- Sponsor
- Janssen Research & Development, LLC
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Opioid Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid-Induced Constipation
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness…
- Trial name
- NCT00672139
- Testing
- Methylnaltrexone bromide
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Bausch Health Americas, Inc.
Postoperative Pain
Phase 2 Herniorrhaphy Study for Opioid Elimination
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
- Trial name
- NCT03695367
- Testing
- HTX-011, Luer lock applicator, Vial access device
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Heron Therapeutics
Opioid-Induced Constipation (OIC)
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative…
- Trial name
- NCT01309841
- Testing
- NKTR-118
- Where
- 117 sites in United States, Australia and 2 more
- Volunteers
- 652 people
- Sponsor
- AstraZeneca
Opioid Overdose
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and…
- Trial name
- NCT05219669
- Testing
- Nalmefene Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Opioid Withdrawal (Disorder)
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
- Trial name
- TAPER (NCT04070157)
- Testing
- Lofexidine
- Where
- 12 sites in United States
- Volunteers
- 4 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Healthy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Trial name
- NCT00604188
- Testing
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Volunteers
- 188 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid Dependence
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine…
- Trial name
- PRO-814 (NCT02180659)
- Testing
- sublingual buprenorphine tablets, Buprenorphine implant
- Volunteers
- 177 people
- Sponsor
- Titan Pharmaceuticals
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101308
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP