Clinical trials: Opioid Dependence
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
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 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
Stable Opioid Dependence
Nalrexone Facilitated Discontinuation of Buprenorphine
The efficacy of buprenorphine as a long-term agonist treatment has been offset by the emergence of intolerable withdrawal phenomena in a subset of individuals on chronic maintenance who attempt to discontinue the medication.
- Trial name
- NCT01895036
- Testing
- Naltrexone
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- New York State Psychiatric Institute
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-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
Opiate Dependence
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX…
- Trial name
- NCT01180647
- Testing
- Extended-Release Naltrexone, Motivational Enhancement Counseling
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- NYU Langone Health
HIV, AIDS
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for…
- Conditions
- HIV, AIDS, Opioid Dependence, Drug Dependence
- Trial name
- NewHope (NCT01246401)
- Testing
- Extended-Release Naltrexone
- Where
- 3 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Yale University
Opiate Dependence
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid…
- Trial name
- NCT00678418
- Testing
- VIVITROL® 380 mg
- Where
- Russia
- Volunteers
- 250 people
- Sponsor
- Alkermes, Inc.
Opioid Abuse, Opioid Addiction
The Discriminative Effects of Tramadol in Humans
This research is part of a set of studies whose purpose is to test whether tramadol can be used for the treatment of opioid addiction. Tramadol is already available in the United States as a pain medicine marketed as Ultram.
- Conditions
- Opioid Abuse, Opioid Addiction, Stimulant Abuse, Stimulant Addiction
- Trial name
- NCT00499746
- Testing
- tramadol, Hydromorphone, Methylphenidate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opiate Dependence, Cocaine Dependence
Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to…
- Trial name
- NCT03527485
- Testing
- 11UCB-J PET Scan
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Yale University
Heroin Dependence, Opioid-Related Disorders
Addiction Treatment in Russia: Oral vs. Naltrexone Implant
Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction treatment often relapse. Therefore, effective heroin addiction treatments are necessary to prevent relapse.
- Trial name
- NCT00218426
- Testing
- naltrexone implant, oral naltrexone
- Where
- 2 sites in United States, Russia
- Volunteers
- 306 people
- Sponsor
- University of Pennsylvania
Opiate Dependence
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone…
- Trial name
- NCT01218984
- Testing
- Medisorb naltrexone 75 mg, Medisorb naltrexone 150 mg, Medisorb naltrexone 300 mg
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Opioid-use Disorder, Opioid Dependence
Remote Observed Dosing of Suboxone to Improve Clinical Practice
This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment…
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opiate Dependence
- Trial name
- NCT03769025
- Testing
- Suboxone Remote Observed Dosing, Suboxone Attention Control
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Pennsylvania
Opioid-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
Opioid Dependence, Opioid Withdrawal
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease…
- Conditions
- Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
- Trial name
- Detox (NCT01262092)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Arkansas
Opioid-Related Disorders, Opioid Dependence
An Innovative Intervention for OUD Treatment
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment.
- Conditions
- Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal
- Trial name
- Bridge (NCT04325659)
- Testing
- Bridge Device, Lofexidine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Opioid-use Disorder
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with long--acting naltrexone (XR--NTX) and to…
- Trial name
- NCT03232346
- Testing
- Vivitrol, Buprenorphine
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute