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Opioid-Related Disorders clinical trials

View clinical trials related to Opioid-Related Disorders.

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NCT ID: NCT04458545 Recruiting - Opioid-use Disorder Clinical Trials

Clinical Trials of Multivalent Opioid Vaccine Components

Start date: October 8, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study is designed to examine a new approach to treating OUD, namely use of a vaccine targeted against oxycodone [Oxy(Gly)4-sKLH], one of the most commonly abused prescription opioids. The vaccination approach to treating substance use disorders relies on the ability of the vaccine to produce antibodies that bind the target drug in blood and reduce its ability to enter the brain. The long-term goal of this research will be to develop a combined vaccine against oxycodone and heroin. However, in this trial the Oxy(Gly)4-sKLH vaccine will be studied separately. This is a multi-site study, being conducted at the New York State Psychiatric Institute and the Clinilabs clinical research unit (CRU) in Eatontown, New Jersey. The current study proposes to evaluate safety (Aim 1), degree of antibody production (Aim 2), and efficacy (i.e., ability to reduced drug liking following opioid administration) (Aim 3). The oxycodone vaccine (Oxy(Gly)4-sKLH) will be tested in participants with OUD (target # completers = 45 across two study sites). This study will provide a great deal of information about the safety and potential effectiveness of the Oxy(Gly)4-sKLH vaccine in reducing the abuse of opioids.

NCT ID: NCT04454645 Recruiting - Parenting Clinical Trials

Intervening With Opioid-Dependent MothersMothers and Infants

mABC
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.

NCT ID: NCT04433975 Recruiting - Chronic Pain Clinical Trials

Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Persist
Start date: August 14, 2020
Phase: N/A
Study type: Interventional

The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.

NCT ID: NCT04408313 Recruiting - Opioid-use Disorder Clinical Trials

Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Start date: October 28, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.

NCT ID: NCT04379115 Recruiting - Chronic Pain Clinical Trials

Optimization of NIBS for Treatment of Addiction

Start date: April 4, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

NCT ID: NCT04375033 Recruiting - Opioid Use Disorder Clinical Trials

A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder

VA-BRAVE
Start date: November 3, 2020
Phase: Phase 4
Study type: Interventional

VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous (in the belly area) formulation of buprenorphine at a target dose of 300mg is superior in retaining Veterans in opioid treatment and in sustaining opioid abstinence compared to the daily sublingual (under the tongue) buprenorphine formulation at a target dose of 16-32 mg (standard of care). This is an open-label, randomized, controlled trial including 952 Veterans with opioid use disorder (OUD) recruited over 3 years and followed actively for 52 weeks. There are a number of secondary objectives that will be studied as well and include: comorbid substance use, both non-fatal and fatal opioid overdose, HIV and Hepatitis B (HBV) and C (HCV) testing results and risk behaviors, incarceration, quality of life, psychiatric symptoms of depression and posttraumatic stress disorder, housing status, dental health and utilization, and cost-effectiveness.

NCT ID: NCT04365920 Recruiting - Opioid-use Disorder Clinical Trials

Recovery Management Checkups for Opioid Use Disorder Experiment

JCOIN-HUB
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The experiment will be conducted in collaboration with 6 jails representing discrete geographic counties in Illinois and the opioid treatment providers (OTP) that serve them. It will compare a re-entry as usual control group with two experimental groups in terms of their impact on the OUD service cascade, as well as public health and public safety outcomes. Study recruitment sites are six jails that provide treatment with medication for opioid use disorder (MOUD) to inmates with OUD prior to their release. At the time of their release to the community, 750 men and women will be randomly assigned to 1 of 3 groups: a) a re-entry as usual control, b) RMC with monthly checkups for 3 months post-release followed by quarterly checkups up to 2 years, or c) an adaptive version of RMC (RMC-A) that includes a modified checkup schedule based on each individual's pattern of treatment need. All participants will complete research interviews at release and quarterly thereafter up to 2 years post-enrollment.

NCT ID: NCT04360681 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans

Start date: March 9, 2021
Phase: Phase 2
Study type: Interventional

The overall objective of the proposed study is to determine if lofexidine (LFX) as an adjunct to buprenorphine (BUP) treatment improves symptoms of both opioid use disorder (OUD) and Post-Traumatic Stress Disorder (PTSD). Other study objectives are to compare the safety, tolerability, and efficacy of BUP treatment alone, to BUP treatment with adjunct LFX, on measures of OUD and PTSD symptoms in Veterans with both prognosis .

NCT ID: NCT04354077 Recruiting - Opioid-use Disorder Clinical Trials

Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.

NCT ID: NCT04345718 Recruiting - Clinical trials for Substance Use Disorder

EXHIT ENTRE Comparative Effectiveness Trial

EXHITENTRE
Start date: August 9, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.