Clinical trials: Opioid Agonist Treatment
Substance Use Disorders
Distress Tolerance for Benzodiazepine Discontinuation
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy (OAT) who currently use benzodiazepines versus a…
- Trial name
- DT-BD (NCT05250570)
- Testing
- Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), Relaxation Therapy
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- University of Pittsburgh
HIV Positive, Opioid Dependence
The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
HIV drug resistance presents a significant public heath problem. This proposal is designed to explore the association between ongoing illicit drug use and the prevalence of HIV drug resistance among HIV+ opioid dependent patients…
- Conditions
- HIV Positive, Opioid Dependence, Opioid Agonist Treatment, HIV Infections
- Trial name
- NCT00857350
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Yale University
Opioid Use Disorder
Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
The goal of this clinical study is to evaluate a new treatment approach called symptom inhibited naloxone induction (SINI) for people with opioid use disorder.
- Trial name
- NCT07439549
- Testing
- Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg), Buprenorphine extended-release injection (300 mg/1.5 mL)
- Where
- 2 sites in Canada
- Volunteers
- 12 people
- Sponsor
- Pouya Azar
Opioid-Related Disorders, Heroin Dependence
Study of Computer-Based Treatment for Drug Dependence
The purpose of this study is to evaluate the whether an automated telephone-based system is useful and helpful for opioid dependent patients receiving buprenorphine in primary care.
- Trial name
- RLSS (NCT01315184)
- Testing
- Recovery Line Support System
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Yale University
Opioid Use Disorder
Methadone Rapid Restart
The usual treatment for opioid use disorder (OUD) is opioid agonist therapy (OAT) with either methadone or buprenorphine. These treatments are well-established, reduce the risk of fatal overdoses, and are considered the standard…
- Trial name
- NCT07546396
- Testing
- Methadone
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Pouya Azar
Opiate Substitution Treatment
Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
This is a randomized trial of two group-based models of care for buprenorphine/naloxone (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management (SMM) and Intensive Outpatient Treatment (IOT).
- Trial name
- NCT02496403
- Testing
- Standard Medical Management (SMM)
- Where
- United States
- Volunteers
- 239 people
- Sponsor
- Kaiser Permanente
Constipation
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
- Trial name
- OIC (NCT01983306)
- Testing
- SP-333 1 mg, SP-333 3 mg, SP-333 6 mg
- Where
- 42 sites in United States
- Volunteers
- 292 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Related Disorders, HIV
Neurocognitive Effects of Opiate Agonist Treatment
The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two types of opioid addiction treatment, on the ability to think and reason among people addicted to opiates, and who are either HIV negative…
- Conditions
- Opioid-Related Disorders, HIV, HIV Infections
- Trial name
- NEO (NCT01733693)
- Testing
- Buprenorphine, Methadone
- Where
- 2 sites in United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
HCV, Opioid Use Disorder
Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine
The goal of this pragmatic, quasi-experimental cluster trial is to evaluate whether simplified, onsite hepatitis C virus (HCV) treatment integrated into opioid agonist maintenance therapy (OAMT) clinics improves cure rates…
- Trial name
- SHIM (NCT07569211)
- Testing
- Simplified HCV Integrated Management, Pay-for-performance, Case Management and Referral
- Where
- Ukraine
- Volunteers
- 616 people
- Sponsor
- Ukrainian Institute on Public Health Policy
Pregnancy Related, Substance Use
The Impact of Opioid and Cannabis Exposure on Fetal Growth
Individually, both opioid and cannabis exposure during pregnancy are associated with changes in fetal growth. The extent to which opioid and cannabis exposure affect fetal growth is unknown.
- Conditions
- Pregnancy Related, Substance Use, Fetal Growth Retardation, Placenta Diseases
- Trial name
- IMPACT (NCT05899101)
- Where
- 5 sites in Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Laura Gaudet
Substance-Related Disorders
Integrated Exercise Program in Opioid Agonist Therapy Clinics
Background: Drug use is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. Particular people with opioid dependence have high morbidity and reduced quality of life.
- Trial name
- BAReAktiv (NCT05242848)
- Testing
- Exercise intervention
- Where
- 2 sites in Norway
- Volunteers
- 309 people
- Sponsor
- Haukeland University Hospital
Post Traumatic Stress Disorder, Opioid-use Disorder
Prolonged Exposure Therapy for PTSD and Opioid Use Disorder
Among patients with opioid use disorder (OUD), 90% report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD).
- Trial name
- NCT04104022
- Testing
- Prolonged Exposure Therapy, Attendance-based monetary incentives
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of Vermont
Opioid Use Disorder
A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse
This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict…
- Trial name
- OPTIMA (NCT03033732)
- Testing
- Methadone, Buprenorphine-Naloxone
- Where
- 7 sites in Canada
- Volunteers
- 272 people
- Sponsor
- Didier Jutras Aswad
Opioid Agonist Treatment, Alcohol Use Disorder
Mobile Platform for Optimizing Wellness and Engagement in Recovery
This pilot study addresses the urgent public health crisis of co-occurring opioid and alcohol use disorders (OUD-AUD), leading causes of mortality in the United States, by testing a scalable digital contingency management (CM)…
- Conditions
- Opioid Agonist Treatment, Alcohol Use Disorder, Opioid Use Disorder
- Trial name
- MPOWER (NCT07178990)
- Testing
- Digital Contingency Management Intervention Arm, Digital Wellness Arm
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Michigan
HIV - Human Immunodeficiency Virus
HIV Prevention With PrEP Among People on Opioid Replacement Therapy
The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta…
- Trial name
- OAT-PrEP (NCT07160075)
- Testing
- Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
- Where
- 6 sites in Canada
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Cara Spence
Smoking Cessation, Substance-Related Disorders
Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco
Background: About 85% of those receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Cigarette smoke lead to lunge diseases and cause illness and death within this group.
- Trial name
- BAReNikotin (NCT05290025)
- Testing
- Nicotine patch, Nicotine gum, Nicotine lozenge
- Where
- 2 sites in Norway
- Volunteers
- 266 people
- Sponsor
- Haukeland University Hospital
Acute Pain
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery.
- Trial name
- NCT00877799
- Testing
- CR845
- Where
- 12 sites in United States
- Volunteers
- 114 people
- Sponsor
- Cara Therapeutics, Inc.
Nicotine Dependence
Tobacco Use in Opioid Agonist Treated Pregnant Women
The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during…
- Trial name
- ROSE (NCT00497068)
- Testing
- tobacco abstinent contingent, non-contingent, control
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Johns Hopkins University
Cocaine Use Disorder
Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
In The Netherlands, each year, about 15 thousand people come into treatment because of problems with cocaine use. There is no approved medication for treatment of cocaine addiction and the psychosocial treatment patients receive…
- Trial name
- NCT05529927
- Testing
- Sustained-release Dexamphetamine
- Where
- Netherlands
- Volunteers
- 204 people
- Sponsor
- Parnassia Addiction Research Centre
Opioid Use Disorder
Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention.
- Trial name
- SARA RCT (NCT06732596)
- Testing
- Embodied conversational agent (ECA), Technical support, Additional ECA messages
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Medical Center