Clinical trials: Opioid Use Disorders
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
Knee Osteoarthritis
An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.
- Trial name
- NCT03661996
- Testing
- CNTX-4975-05, Lidocaine without epinephrine, ElastoGel
- Where
- 28 sites in United States
- Volunteers
- 854 people
- Sponsor
- Centrexion Therapeutics
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.
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 Dependence
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4.
- Trial name
- NCT02038790
- Testing
- Suboxone Sublingual Film, Zubsolv sublingual tablets
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indivior Inc.
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, 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 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, 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
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 (OUD)
A Safety Study of AZD4041 in Healthy Participants
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy male and female adult participants.
- Trial name
- NCT05233085
- Testing
- AZD4041
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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.
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
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
mHealth for Patient Self-Management of Opioid Use Disorder
Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.
- Trial name
- NCT03633929
- Testing
- KIOS OUD
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biomedical Development Corporation
Opioid Use Disorder
Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to…
- Trial name
- NCT02044094
- Testing
- Buprenorphine, buprenorphine and naloxone, hydromorphone
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Indivior Inc.
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.
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 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