Clinical trials: Opiate-Related Disorders
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)
Opiate Addiction
Onsite Buprenorphine Treatment at Syringe Exchange Programs
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community…
- Trial name
- O-BMT (NCT03150173)
- Testing
- Onsite treatment, Enhanced referral, Buprenorphine
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- Montefiore Medical Center
Opioid-Related Disorders, Opiate Substitution Treatment
Slow-Release Oral Morphine for the Treatment of Opioid Use Disorder
This is a non-inferiority randomized clinical trial that will compare slow release oral morphine vs methadone as a second line oral treatment for opioid use disorder.
- Conditions
- Opioid-Related Disorders, Opiate Substitution Treatment, Morphine, Methadone
- Trial name
- pRESTO (NCT03948464)
- Testing
- Slow release oral morphine (SROM), Methadone
- Where
- Canada
- Volunteers
- 27 people
- Sponsor
- M. Eugenia Socias
Opioid Overdose, Opioid Use
Machine-Learning Prediction and Reducing Overdoses With EHR Nudges
The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction…
- Conditions
- Opioid Overdose, Opioid Use, Opioid Use Disorder, Opioids
- Trial name
- mPROVEN (NCT06806163)
- Testing
- EHR-Embedded Elevated-Risk Flag, EHR-Embedded Elevated-Risk Flag with Behavioral Nudges, Usual Care
- Where
- United States
- Volunteers
- 1,350 people
- Sponsor
- University of Pittsburgh
Cocaine, Substance Abuse
The Maternal Lifestyle Study (MLS)
This is a longitudinal, multi-site observational study of the long-term effects of a mother's use of cocaine and/or opiates during pregnancy on her infant.
- Conditions
- Cocaine, Substance Abuse, Infant, Newborn, Pregnancy
- Trial name
- MLS (NCT00059540)
- Where
- 5 sites in United States
- Volunteers
- 11,811 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Opioid Overdose
Improving Availability of Intranasal Naloxone
While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose, patients often fail to fill the prescription at the pharmacy when it is prescribed.
- Trial name
- NCT05877118
- Testing
- Enhanced Overdose Education (EOE), Standard education
- Where
- 2 sites in United States
- Volunteers
- 84 people
- Sponsor
- Hartford Hospital
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.
Opioid-Related Disorders
Activity Monitoring Assessment of Opiate Withdrawal - 4
The purpose of this study is to determine if hyperactivity accompanies abrupt opiate withdrawal in heroin addicts, to determine if computerized solid state activity monitors are capable of quantifying hyperactivity, and to…
- Trial name
- NCT00000335
- Testing
- Morphine
- Where
- United States
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid-use Disorder, Tobacco Use Disorder
Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
The goal of this study is to examine the effect of four sessions of theta burst stimulation (TBS) versus sham TMS on attentional bias for smoking and opioid cues versus neutral stimuli in a population of patients with tobacco use…
- Trial name
- NCT05049460
- Testing
- Theta Burst Stimulation
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Gopalkumar Rakesh
Opioid-use Disorder, Opioid-related Disorders
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine…
- Trial name
- RECOVER® (NCT03604861)
- Testing
- Not applicable - no defined intervention
- Where
- 35 sites in United States
- Volunteers
- 534 people
- Sponsor
- Indivior Inc.
HIV Infections, Opioid-Related Disorders
Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently the major mode of transmission of HIV in many countries.
- Trial name
- NCT00270257
- Testing
- Buprenorphine/Naloxone
- Where
- 4 sites in China, Thailand
- Volunteers
- 1,251 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Addiction Opiate, Chronic Pain
Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population
This is a randomized controlled trial. Patients will be randomly assigned to either the control or treatment group, with equal allocation using block randomization.
- Conditions
- Addiction Opiate, Chronic Pain, Fractures, Bone, Buprenorphine Dependence
- Trial name
- SUPER-ERAS (NCT04464512)
- Testing
- Sufentanil
- Where
- United States
- Sponsor
- West Virginia University
Opiate Dependency Relapse
Using mHealth to Aid Opioid Addicts
The purpose of the proposed study is perform focus groups to identify and prioritize features of the SubAID application (APP). The SubAID APP is smartphone APP being created to support patients self-managing…
- Trial name
- NCT01955902
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Care Team Solutions
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid-Related Disorders
Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy
The patient's compliance to his medication therapy, and therefore the success of the treatment, is particularly related to his pharmacy management.
- Trial name
- SATISFY (NCT03961789)
- Testing
- patients undergoing opioid replacement therapy
- Where
- France
- Volunteers
- 98 people
- Sponsor
- University Hospital, Clermont-Ferrand
Opiate Dependence, Chronic Pain
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
This double-blind, randomized, controlled trials will investigate the effect of accelerated, repeated transcranial magnetic stimulation on opiate craving and perceived pain .
- Trial name
- ArTMS (NCT03538444)
- Testing
- Repetitive Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Medical University of South Carolina
Opioid Use, Stimulant Use
THRIVE: Culturally AdapTed Harm Reduction Intervention
The goal of this study is to develop and test a culturally adapted harm reduction intervention among Black adults who misuse opioids and/or stimulants.
- Trial name
- NCT06609278
- Testing
- harm reduction intervention
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Brittany Miller-Roenigk
Opioid-use Disorder
Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment
A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines.
- Trial name
- TOPAZE (NCT03729388)
- Testing
- Prognosis factor associated with good outcome.
- Where
- 2 sites in France
- Volunteers
- 29 people
- Sponsor
- Nantes University Hospital
Opioid Abuse
Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Death in overdose is the single most common cause of death in people using heroin. In Sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s.
- Trial name
- NCT03570099
- Testing
- Naloxone Nasal Spray, Historical control cohort
- Where
- Sweden
- Volunteers
- 2,000 people
- Sponsor
- Region Skane
Cocaine Dependence, Opiate Dependence
Cocaine Withdrawal and Pharmacotherapy Response
A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day)…
- Trial name
- Carvedilol (NCT00566969)
- Testing
- sugar pill, Carvedilol 25 mg, Carvedilol 50 mg
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Yale University