The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers...
Opioid Use DisorderThis study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.
The OPT-IN Project
Opioid-Related DisordersPrescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use. The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
Access to Primary Care for People With Opioid Use Disorder
Access to Primary CareBackground: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a primary care provider. The reasons are unclear, but may be related to patient factors, system barriers and provider factors, including discrimination. Research goal: Our primary goal is to determine if discrimination by primary care physicians plays a role in poor access to primary care for those in treatment for OUD. The answers will help researchers and policy-makers find ways to improve access to primary care for this vulnerable population. Research question: Are people in treatment for OUD less likely to be offered a new patient appointment with a physician compared to those in treatment for diabetes? Overall study design: In this randomized controlled trial (RCT), the investigators will make unannounced phone calls to primary care physicians' practices to ask for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes, or a patient in treatment for OUD. Our outcome measure is an unconditional offer of a new patient appointment with the physician contacted or with another physician at the same practice. In an secondary analysis the investigators will determine the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment. Participants: Randomly-selected primary care physicians in Ontario. Data analysis methods: The investigators will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.
Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program...
HIV Prevention ProgramOpioid-use DisorderThis is a pilot study of an integrated rapid access HIV prevention program for People who inject drugs (PWID) called iRaPID. The program incorporates same-day access to Pre-exposure Prophylaxis (PrEP) and Opioid Agonist Therapy (OAT).
Medication Development for Opioid and Alcohol Abuse
Opioid-use DisorderAlcohol Use DisorderThe present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants with both Opioid Use Disorder and Alcohol Use Disorder.
Opioid Use Disorder in the Emergency Department: CTN 0069
Opioid Use DisorderThe purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.
Cocaine Opioid Oxytocin Option - Limited
Opioid Use DisorderCocaine Use DisorderThis is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.
Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT
Opioid-Related DisordersHeroin DependenceThe aim of this project is to study brain functions of 20 heroin addicts (compared to brain functions of 20 healthy controls) just before and during a three month extended release naltrexone treatment using functional MRI and dopamine transporter SPECT. The following hypotheses are tested: XRNT modulates the fMRI response to drug cues in predetermined brain regions. The expression of striatal transporters (assessed with SPECT) will decrease after a three-month course of extended release naltrexone
Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
Opioid AbuseOpioid DependenceOpioid drugs increase glial cell activation which may be related to the abuse liability of opioid drugs. Data supporting this hypothesis have demonstrated that glial cell attenuators decrease the positive rewarding aspect of opioids in laboratory animals. Ibudilast (MN-166, formerly AV411) is a compound that inhibits the activation of glia. Recent preclinical studies demonstrate that while ibudilast increases the analgesic effects of opioids, it decreases the rewarding effects of such drugs. It has also been shown that ibudilast suppresses morphine-induced release of dopamine, a primary neurotransmitter involved in the rewarding and reinforcing effects of abused drugs. Additionally, we recently found that ibudilast decreases subjective symptoms of opioid withdrawal in opioid dependent humans during detoxification. Therefore, the primary aim of this 6-7 week inpatient study is to investigate the ability of MN-166 to dose-dependently alter the reinforcing, analgesic, subjective, performance, and physiological effects of oxycodone, a commonly abused prescription opioid. This study includes a 10-day morphine taper phase, followed by two study phases (approximately 18 days each) with daily active ibudilast and placebo administration, respectively. After the detoxification phase, participants are randomized to receive placebo or MN-166, and then be stabilized on the medication. Thereafter, participants will complete laboratory sessions. Subsequently, during Phase 2, participants will cross over to the other treatment arm, stabilize, and complete laboratory sessions.
Prescription Opioid Effects in Abusers Versus Non-Abusers
Opioid-Related DisordersSubstance-Related DisordersThe purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.