Clinical trials: Opioid-Related Disorders
Post Traumatic Stress Disorder, Alcohol Abuse
Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
Objective: Evaluate the efficacy and physiological effects of sublingual buprenorphine (SL-BUP; Subutex) combined with extended-release injectable naltrexone (XR-NTX; Vivitrol) in the treatment alcohol use disorder of comorbid…
- Trial name
- NCT03852628
- Testing
- 2mg Buprenex and 380mg Vivitrol
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Low Back Pain
Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction.
- Trial name
- NCT01559454
- Testing
- Methadone, Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- State University of New York at Buffalo
Opioid Overdose
Project OOPEN: Opioid Overdose Prevention, Education and Intervention
This prospective, randomized emergency department trial will study the effectiveness of an intervention that combines opioid overdose prevention, education and intervention that includes take home naloxone with brief behavioral…
- Trial name
- OOPEN (NCT01788306)
- Testing
- OOPEN+BBCC
- Where
- 3 sites in United States
- Volunteers
- 256 people
- Sponsor
- University of Washington
Opioid-use Disorder
Evaluation of Long-term Buprenorphine Plasma Exposure
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.
- Trial name
- NCT03752528
- Testing
- Blood sample collection, Urine sample collection
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Indivior Inc.
Substance-Related Disorders
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped.
- Trial name
- NCT00661674
- Testing
- Palonosetron, Hydroxyzine
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Stanford University
Constipation
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
- Trial name
- NCT00529087
- Testing
- N-methylnaltrexone bromide (MOA-728)
- Where
- 78 sites in United States
- Volunteers
- 460 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid Use Disorder, Chronic Pain
Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management
The investigators plan to develop and pilot test an integrated, web-based cognitive behavioral approach and then conduct a randomized clinical trial evaluating its efficacy relative to standard care in a large and diverse sample…
- Trial name
- IMPACT (NCT05204576)
- Testing
- CBT4CBT COPES
- Where
- 3 sites in United States
- Volunteers
- 160 people
- Sponsor
- Yale University
Substance Use
Telehealth-Clinical Advocacy Project
The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.
- Trial name
- (T-CAP) (NCT04911426)
- Testing
- Telehealth
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Texas Christian University
Tobacco Use Disorder
Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high…
- Trial name
- P2S2 (NCT02250664)
- Testing
- Very low nicotine content cigarettes
- Where
- 2 sites in United States
- Volunteers
- 775 people, healthy volunteers welcome
- Sponsor
- University of Vermont
Opioid Dependence
Dronabinol Naltrexone Treatment for Opioid Dependence
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals.
- Trial name
- Domino (NCT01024335)
- Testing
- injectable naltrexone and dronabinol
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- New York State Psychiatric Institute
Low Back Pain, Opiate Addiction
Study of Opioid Use After Lumbar and Cervical Spine Surgery
The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery.
- Conditions
- Low Back Pain, Opiate Addiction, Neck Pain
- Trial name
- SOULCS (NCT02674711)
- Testing
- Educational Video
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Brooke Army Medical Center
Opioid-use Disorder
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR
The primary objective of this pilot study is to program an opioid use disorder (OUD) clinical decision support (CDS) tool for use in an electronic medical record (EMR) and obtain high primary care physician (PCP) usability and…
- Trial name
- COMPUTE (NCT03559179)
- Testing
- Opioid Wizard
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- HealthPartners Institute
HIV Prevention, Opioid-Related Disorders
Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1
Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse…
- Trial name
- NCT00142935
- Testing
- Pre-release Initiation of MMT, Post Release Initiation of MMT., Standard of Care Plus
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- The Miriam Hospital
Opioid Dependence
Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse
In this study, we will assess opioid self-administration in a laboratory setting in persons with pain who have a history of opioid abuse.
- Trial name
- PAIN (NCT01967641)
- Testing
- buprenorphine/naloxone combination
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- New York State Psychiatric Institute
Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
SUBLOCADE Rapid Initiation Extension Study
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
- Trial name
- NCT04060654
- Testing
- Sublocade
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indivior Inc.
Opioid-use Disorder, Anxiety Disorders
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems.
- Conditions
- Opioid-use Disorder, Anxiety Disorders, Depressive Disorder
- Trial name
- NCT05047627
- Testing
- Smartphone-Based Digital Intervention
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Trustees of Dartmouth College
Opioid-use Disorder, Opiate Dependence
Impact of Lofexidine on Stress, Craving and Opioid Use
Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks.
- Trial name
- NCT03718065
- Testing
- Lofexidine
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Medical University of South Carolina
Opioid Abuse
Community Trial in the Cherokee Nation
The target population is students attending high schools in small rural towns in the 14 counties that partially or fully fall within the Cherokee Nation reservation.
- Trial name
- NCT04839978
- Testing
- Connect Program, Communities Mobilizing for Change and Action (CMCA)
- Where
- United States
- Volunteers
- 919 people
- Sponsor
- Emory University
Smoking Cessation
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence.
- Trial name
- B-EPIC (NCT03796208)
- Testing
- Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC), Treatment As Usual
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Kristin Ashford
Opioid-Related Disorders
Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings
In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of…
- Trial name
- DC (NCT02978417)
- Testing
- Naltrexone for extended-release injectable suspension, Oral naltrexone
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Duke University