78 Clinical Trials for Various Conditions
This is a randomized controlled trial. Patients will be randomly assigned to either the control or treatment group, with equal allocation using block randomization. The primary null hypothesis is that a combination sufentanil and buprenorphine based pain control regimen will not result in lower morphine equivalent requirements for pain control when compared to a classic fentanyl and hydromorphone based regimen. The secondary working hypothesis is that the patient satisfaction survey mean satisfaction scores will be higher in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The secondary null hypothesis is that the patient satisfaction surveys mean scores will not be significantly different in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The tertiary working hypothesis is that the patients will have significantly lower rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks. The tertiary null hypothesis is that patients have equivalent rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks.
Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can be high, and reducing illicit opiate use during treatment has thus recently become a major NIDA policy goal. The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days.
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 healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan. This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.
The purpose of this study is to examine the efficacy of DBT compared to a standard drug counseling approach for the treatment of opiate addiction and borderline personality disorder (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted individuals to be the among the most challenging for therapists. DBT has established itself as one of the most effective treatments for treatment retention of these patients and for reducing parasuicidal and self-injurious behaviors. This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has been shown to be efficacious for the treatment of BPD patients and it has been extended in this study to target addictive behaviors in these patients. The study consists of three treatment parts: weekly individual and group therapy and suboxone maintenance medication. Participants are provided therapy on a weekly basis for one year and suboxone for 2 years. Assessments for tracking outcome are conducted every 4 months. It is hypothesized patients in the DBT condition will show a reduction of substance use, parasuicidal and other psychological difficulties and these gains will be maintained through the year of follow-up assessments. In addition, it is predicted that adherence to DBT treatment protocols will be associated with improved outcomes. Finally, it is predicted that treatment "dosage" (average hours of therapy/week) will be positively related to clinical improvement.
Methadone is a drug that offers significant therapeutic benefits to opiate dependent women who are pregnant. Currently, it is the treatment of choice for this group of people. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.
This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. There are 4 specific aims but only specific aim 4 is a clinical trial and reported here. In specific aim 4, eligible consenting women on buprenorphine in an MAT clinic will be assigned to 2 dose reduction regimens and their response to dose reduction will be measured using a visual analog scale.
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.
The primary purpose of this study is to determine whether buprenorphine and metabolite exposure (reflected as the dose-adjusted plasma concentration x time curve \[AUC\]) differs during pregnancy and between pregnancy and the postpartum state.The study will define the pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing based on objective, physiological parameters of satiety. The study will define neonatal exposure to buprenorphine through breast milk.
The investigators have designed a single site, Phase IV open label, prospective observational clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus standard postpartum contraceptive care (control) on consistent contraceptive use and rapid repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.
Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.
This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any smartphone to automate directly observed therapy (Automated DOT®). Real-time patient adherence data are encrypted and automatically sent to a centralized web-based dashboard for use by healthcare professionals or research staff. Unlike Facetime® or Skype®, the system relies on computer vision algorithms to confirm the process of medication administration; no human review is necessary. The purpose of this study is to evaluate the feasibility and acceptability, and measure the accuracy, of the AiCure platform ("platform") in patients being treated for opioid dependence with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1) to assess the feasibility and acceptability to both participants and study staff in using AiCure to monitor medication adherence; 2) to evaluate the acceptability of using AiCure to optimize care pathways; and 3) to measure the reliability and validity of AiCure in detecting interruptions in treatment. To assess feasibility and acceptability of the platform, we will measure rates of physician satisfaction and user acceptance. Optimization of care pathways will be measured by assessing the sustainability of AiCure use over 12 weeks (retention rates) and measuring illicit opioid use (urine drug screens) compared to historical data. Reliability and validity of AiCure will be measured by comparing AiCure adherence against pharmacokinetic data. All participants will be requested to take each of their prescribed doses using the app. Participants will be able to download the app onto their own smartphone or will be provisioned a device at the start of the study. The data captured during the medication ingestion process will be automatically encrypted and stored on the participant smartphone and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be sent to study staff via email or SMS to prompt immediate intervention. In addition, all participants will receive treatment as usual.
Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.
Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.
This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. The investigators hypothesize that naltrexone treatment is as effective as buprenorphine/naloxone for these treatment outcomes.
This study is designed to examine the effects of combined buprenorphine and voucher incentives to promote abstinence from illicit opiate use, along with or without computer-delivered therapy, during treatment of opioid dependence.
Patients with heroin and prescription opioid dependence are at increased risk for adverse health consequences and often utilize the Emergency Department (ED) as their source of medical care. Screening, brief intervention and referral to treatment has been effective in decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices. The data on the effectiveness of brief interventions with opioid dependence is limited. This prospective, randomized controlled trial of opioid dependent subjects (N=360) will compare two models of brief intervention with a control condition. ED patients with opioid dependence will be randomized to either: (1)Screening, Brief Intervention with a Facilitated Referral to Treatment (SBIRT); (2) Screening, Brief Intervention with ED initiated Buprenorphine Treatment (SBI+Bup); or (3) standard care (SC) which includes a handout detailing substance abuse treatment centers in the area. The primary outcome will be self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program. Other outcomes measured at 30 days, 2, 6 and 12 months include changes in opioid use (self-report and urine toxicology analysis), HIV risk behaviors, and health care service utilization. The three interventions will also be compared on their cost-effectiveness. We will test the hypotheses that SBI+Bup will be superior to SBIRT and SC, and SBIRT will be superior to SC in (1)increasing the proportion of patients engaged in formal substance abuse treatment at 30 days; (2) reducing illicit opioid use; (3) reducing HIV risk behaviors; and (4) reducing health care service utilization. In addition, we hypothesize that the societal costs of SBI+Bup, per number of days of opioid abstinence, will be cost effective relative to SBIRT or SC; and that SBIRT will be cost effective relative to SC. Data analyses will be conducted on the intention to treat sample of randomized patients. This study, conducted by a research team with extensive experience evaluating brief interventions and treatments for opioid dependence, will be unique in its: (1) comparison of two models of brief intervention with standard care; (2) inclusion of an ED initiated treatment arm; (3) use of manual-guided interventions with systematic assessment of adherence and competence; and (4)collection of detailed cost data to help guide future healthcare policy.
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.
This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.
The main objective of this study is to investigate the effectiveness of lofexidine in reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently, lofexidine is the most commonly used non-opiate medication for detoxification from opiates in the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug Administration (FDA) for the same indication in the United States (US). The only medications currently approved by the FDA for opiate detoxification are methadone and buprenorphine. These medications, however, have the potential to be abused. Lofexidine, on the other hand, offers a unique advantage for opiate detoxification because it is not addicting, is easy to use, and has a favorable safety profile.
The purpose of this study is to compare a one year treatment program of Dialectical Behavior Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) + suboxone.
STRIDE2 is a longitudinal, non-randomized study of individuals living with HIV who are dependent on opioids. This study is funded by the National Institute on Drug Abuse (R01DA030768, Altice, PI; Taxman \& Lawson, Co-PIs) and is being conducted by George Mason University, Yale University, and Howard University.
Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. It is meant to provide motivation for continued abstinence while enhancing social stability. In this study, treatment was offered to inner city opiate and cocaine users immediately following a brief medically-supported residential detoxification. Previous research had shown that RBT produces 3- month outcomes superior to those for patients who are referred to outpatient treatment in the community. The present study compared outcomes for patients (N = 243) randomly assigned to receive abstinence-contingent recovery housing with (full RBT) or without additional intensive counseling or to receive usual care referral to outpatient treatment following detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received recovery housing with (full RBT) and without additional counseling and both these treatments were superior to usual care referral. Study findings support the efficacy of post-detoxification recovery housing with or without counseling for opiate and cocaine users.
The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.
The purpose of this study is to evaluate the effect on pain intensity (PI) of structured discontinuation of long-term opioid analgesic therapy compared to continuation of opioid therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic therapy for chronic low back pain (CLBP).