Clinical trials: Opioid Use Disorder
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder, Opioid-related Disorders
Open-Label Treatment Extension Study
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
- Trial name
- NCT02896296
- Testing
- RBP-6000
- Where
- 29 sites in United States
- Volunteers
- 208 people
- Sponsor
- Indivior Inc.
Parenting, Opioid-use Disorder
Fathering In Recovery
The majority of men experiencing opioid use disorder and receiving treatment are fathers. Substance use, transitions between in-patient and out-patient treatment, and reunification as a family, all create considerable strain and…
- Conditions
- Parenting, Opioid-use Disorder, Father-Child Relations, Fathers
- Trial name
- FIR (NCT04611542)
- Testing
- Fathering In Recovery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Opioid Use Disorder, Chronic Pain
Phase II Pharmacokinetics Study of CAM2038
Phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.
- Trial name
- NCT02710526
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Braeburn Pharmaceuticals
Opioid Use Disorder
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in…
- Trial name
- NCT04669249
- Testing
- PROCare
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medical Decision Logic, Inc.
Opioid Use Disorder
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
The purpose of this open label study is to characterise the absorption, metabolism, excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male participants.
- Trial name
- NCT05974046
- Testing
- [14C]IDV184001AN
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Healthy Volunteer Study, Opioid-use Disorder
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
The primary objectives of this study are to evaluate the safety and tolerability of KNX100 administered orally as a single and multiple ascending doses in healthy volunteers.
- Trial name
- KTX101 (NCT04901078)
- Testing
- KNX100
- Where
- Australia
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Kinoxis Therapeutics Pty Ltd
Postoperative Pain
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03295721
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 15 sites in United States
- Volunteers
- 412 people
- Sponsor
- Heron Therapeutics
Opioid Dependence, Opioid Related Disorders
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
- Trial name
- NCT02357901
- Testing
- SUBOXONE, RBP-6000
- Where
- 38 sites in United States
- Volunteers
- 665 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants
The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine.
- Trial name
- NCT04448561
- Testing
- ASP8082, morphine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of…
- Trial name
- NCT02696434
- Testing
- Naltrexone, Buprenorphine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Alkermes, Inc.
Nondependent Opioid Abuse, Episodic
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to…
- Trial name
- NCT01380093
- Testing
- MS Contin (morphine sulfate, controlled release), EMBEDA (morphine sulfate / naltrexone hydrochloride)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid Use Disorder
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users.
- Trial name
- NCT05587998
- Testing
- Morphine, AZD4041
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Opioid-use Disorder
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC)…
- Trial name
- NCT04948307
- Testing
- OXD01 digital therapy, Standard of Care
- Where
- 21 sites in United States
- Volunteers
- 437 people
- Sponsor
- Orexo AB
Opioid-use Disorder, Contingency Management
Usability Testing for the Reward-based Technology to Improve OUD Treatment
Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden.
- Conditions
- Opioid-use Disorder, Contingency Management, Medication for Opioid-use Disorder
- Trial name
- OARSCM (NCT05159362)
- Testing
- Software Application
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Q2i, LLC
Opioid Use Disorder
Reward-based Technology to Improve OUD Treatment
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common…
- Trial name
- OARSCM (NCT05180669)
- Testing
- OARSCM Software Application, MyMAT Software Application
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Q2i, LLC
Opioid Use Disorder, Opioid-related Disorders
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled.
- Trial name
- NCT02510014
- Testing
- SUBOXONE sublingual film, RBP-6000
- Where
- 42 sites in United States
- Volunteers
- 775 people
- Sponsor
- Indivior Inc.
Moderate or Severe Opioid Use Disorder
A Multiple Dose Opioid Challenge Study
Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use…
- Trial name
- NCT02611752
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Braeburn Pharmaceuticals
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.