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Opioid Dependence clinical trials

View clinical trials related to Opioid Dependence.

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NCT ID: NCT03789214 Completed - Sleep Disturbance Clinical Trials

Medical Management of Sleep Disturbance During Opioid Tapering

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.

NCT ID: NCT03769025 Completed - Opioid-use Disorder Clinical Trials

Remote Observed Dosing of Suboxone to Improve Clinical Practice

Start date: April 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

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 of opiate dependence by prompting patients to take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug Administration (FDA) for the treatment of opiate dependence. All patients receive a smartphone and patients in the intervention (remote observed dosing) group will use the smartphone to take videos of themselves taking Suboxone.

NCT ID: NCT03684681 Completed - Opioid Use Clinical Trials

The Navigator Trial

Start date: November 14, 2018
Phase: N/A
Study type: Interventional

In this study, the investigators will investigate if there is a better intervention for patients who present to the emergency department with an overdose or with symptoms consistent with drug use. There are currently two interventions that are routinely used when a patient comes to the Emergency Department with these criteria, and the investigators will compare the two. The first is when hospital social workers uses their own previous training to help people meet their goals. The second is when a person called a peer navigator, who is someone that has been in long-term drug recovery for over two years and has completed a lot of training to work with current drug users, delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals. The investigators hope to determine if patients have better outcomes if they work with one of these two groups. If a patient agrees to be in the study, the research staff will randomize them (like flipping a coin) to see if they will work with a social worker or a peer navigator. The research staff will distribute a survey in RedCap and the following information will be collected: age, sex, race, type of opioid used, and history of chronic pain, depression or post-traumatic stress disorder. Once the patient is assigned to a group, they will work with their assigned interventionist for the duration of the study. After this, the research team will track the patient to see if they joined an addiction-treatment program within 30 days of when the joined the study. The study team will also track patients to see if they had additional emergency department visits, additional overdoses, and if they successfully completed a treatment program over an 18-month period. 650 patients will be enrolled into the study.

NCT ID: NCT03611335 Completed - Opioid Dependence Clinical Trials

A Pragmatic Trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) Model for Engaging Patients in Opioid Use Disorder Treatment

CATCH
Start date: December 7, 2018
Phase:
Study type: Observational [Patient Registry]

This pragmatic clinical trial seeks to evaluate the effectiveness of the Consult for Addiction Treatment and Care in Hospitals (CATCH) intervention as a strategy for engaging patients with Opiod Use Disorder (OUD) in addiction treatment.

NCT ID: NCT03604159 Completed - Opioid Dependence Clinical Trials

XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

Start date: June 24, 2019
Phase: Phase 4
Study type: Interventional

This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.

NCT ID: NCT03603158 Completed - Opioid Dependence Clinical Trials

KCNH2 Polymorphisms on the QTc Interval in Kelantanese Malays Patients Receiving Methadone Maintenance Therapy (MMT)

Start date: February 1, 2011
Phase:
Study type: Observational

Methadone maintenance therapy (MMT) is one of the modalities to prevent HIV transmission among injected drug users, particularly in opioid-dependent users. However, methadone-associated cardiotoxicity is one of the fatal adverse events that limit the widespread usage in certain groups of opioid-dependent patients. This is a cross-sectional study aimed to investigate the association between 4 KCNH2 SNPs (1539C>T, in exon 6 of KCNH2 gene; 1956T>C, in exon 8 of KCNH2 gene), 2350C>T (in exon 9 of KCNH2 gene), 2690A>C (Exon 11 of KCNH2 gene)) and prolongation of QTc interval in opioid-dependent Kelantanese Malays who are the recipients of Methadone Maintenance Therapy. The investigators hypothesized that subjects with minor alleles of those 4 SNPs will have longer QTc intervals than those with major alleles, adjusting for the effects of other confounding factors such as age and gender of the subjects, plasma methadone trough levels, hypokalemia, hypocalcemia and hypomagnesemia. The investigators also aimed to provide a model that will reliably predict the magnitude QTc based on the SNPs data and other covariates mentioned above. This will greatly assist in identifying methadone recipients who are at risk of developing prolonged QTc or the more fatal torsade de pointes.

NCT ID: NCT03576781 Completed - Pain Clinical Trials

Developing rTMS Treatment Strategies for Pain in Opiate Dependence

Start date: February 9, 2017
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to parametically evaluate two different types of repetitive Transcranial Magnetic Stimulation (rTMS) treatment strategies as a potential treatment for pain in individuals currently taking prescription opiates. Repetitive TMS is a non-invasive tool that uses magnetic pulses to temporarily stimulate specific brain areas. This study will test whether rTMS over different locations of the prefrontal cortex can produce a reduction in an individuals perception of pain and how the brain responds to pain. Participants will be randomized to receive either sham-rTMS, or one of two real rTMS treatments. Brain imaging, behavioral assessments, and pain assessments will be collected both immediately before and after rTMS.

NCT ID: NCT03575273 Completed - Obesity Clinical Trials

The Impact of Methadone Maintenance Therapy on Food Reward Processing in Opioid Dependence

Start date: February 12, 2018
Phase: N/A
Study type: Interventional

Methadone maintenance therapy (MMT) has shown clear efficacy for relieving opioid withdrawal symptoms and reducing the morbidity and mortality of opioid dependence. A notable phenomenon associated with MMT is increased food intake, enhanced sweet preferences, and weight gain. The underlying neural mechanisms for opioid-related overconsumption are not well understood but are thought to arise from role in 1) increasing the palatability and hedonic aspects of food and 2) diminishing satiety signaling systems. In the proposed project, the investigators will examine methadone's potential role in opioid-related overconsumption of food. The investigators propose to examine eating behavior, sucrose preferences, and an event-related potential (ERP) component that is induced by appetitive motivation for highly rewarding foods in patients with a history of opioid dependence receiving methadone maintenance therapy (O+MMT) and not receiving opioid agonist therapy (O-MMT). A matched sample of obese and overweight adults without history of opioid use (HOC) will also be examined.

NCT ID: NCT03567356 Completed - Clinical trials for Opioid-Related Disorders

Treatment of Opioid Use: Medication Adherence Therapy

MAT-PLUS
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

To test the feasibility and acceptability of a novel approach for improving the delivery and effectiveness of XRNTX treatment for opioid use disorder (OUD) - the MAT-PLUS intervention. The components of the MAT-PLUS intervention are: XRNTX, initiated during an episode of inpatient/residential treatment and dosed monthly, provides opioid receptor blockade, relapse prevention and overdose prevention; Significant other engagement empowers family members or other designated concerned others, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; Assertive outreach incorporates frequent multi-channel outreach, in a model that specifically targets engagement and motivation for medication adherence; Counselor care coordination and case management focused on medication management and adherence. This objective #1 will be accomplished by conducting a small-scale, 2-arm, open label, RCT pilot study of 4 months of treatment with the MAT-PLUS intervention (significant other engagement and training, medication care coordination by counselors, assertive outreach) + TAU (monthly doses of XRNTX + routine counseling), vs TAU for n=40 (20 per arm) patients with OUD. Adult patients ages 18+ who receive an initial dose of XRNTX during an index episode of inpatient/residential/detox treatment for opioid addiction at a public-sector community treatment program treatment, with intention to continue in outpatient treatment. The experimental arm will receive the MAT-PLUS intervention for 4 months of ongoing outpatient treatment with XRNTX. The control arm will receive 4 months of standard TAU (XRNTX + clinic-based counseling) without MAT-PLUS. At the beginning of the trial an additional small (N = 4 or 5) group of test patients will receive the MAT-PLUS intervention to test and refine the study procedures.

NCT ID: NCT03447743 Completed - Opioid Dependence Clinical Trials

Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder

Start date: September 11, 2019
Phase: Early Phase 1
Study type: Interventional

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural individuals with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural individuals with OUD, and the dearth of available and accessible evidence-based treatment in the region. This study has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce the prevalence of opioid use disorders and related health disparities among hard-to-reach, high-risk, underserved populations.