Clinical trials: Substance Misuse
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Opioid-use Disorder, Opioid Misuse
Comparing a Patient Self-Assessment Software to Treatment as Usual in Opioid Prescriber and Patient Opioid Outcomes
The Care Continuity Program (CCP), a product of Sure Med Compliance, is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit.
- Conditions
- Opioid-use Disorder, Opioid Misuse, Opioid Use, Chronic Pain
- Trial name
- NCT04945525
- Testing
- Care Continuity Program
- Where
- United States
- Volunteers
- 1,840 people
- Sponsor
- Sure Med Compliance
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.
Opioid Overdose
Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
- Trial name
- NCT07543276
- Testing
- Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Knoa Pharma LLC
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
Relationship Conflict, Relationship Distress
OurRelationship-S: A Digital Relationship-Strengthening Program for Couples Experiencing Substance Misuse
This study tests the effectiveness of an online relationship program that has been tailored for couples in which one or both members are in recovery from substance misuse.
- Trial name
- NCT07159633
- Testing
- Online Couple Intervention
- Where
- 5 sites in United States
- Volunteers
- 120 people
- Sponsor
- OurRelationship
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
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
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 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
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
A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02751762
- Testing
- Observation Only
- Where
- 2 sites in United States
- Volunteers
- 3,600 people
- Sponsor
- Member Companies of the Opioid PMR Consortium