Treatment Trials

136 Clinical Trials for Various Conditions

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COMPLETED
Developing rTMS Treatment Strategies for Pain in Opiate Dependence
Description

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.

COMPLETED
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Description

The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Conditions
COMPLETED
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Description

This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. While stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter. Participation for all individuals will last 4 months. Assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).

UNKNOWN
Oxytocin in Opiate Dependence: A Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence
Description

Opiate dependence is a serious problem, and oxytocin has many properties which make it attractive as a treatment for this type of substance dependence. This experiment will test the effects of oxytocin on a variety of brain-based processes in patients with opiate dependence. The investigators hypothesize that intranasal oxytocin in these conditions will enhance emotional processing and will have beneficial effects on stress responses in opiate-dependent patients.

TERMINATED
Anxiety in Recovering Opiate Dependence
Description

This is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized anxiety disorder (GAD) in subjects with comorbid opiate dependence. The study will be conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. Study subjects will be inpatients at a residential drug-treatment facility, enrolled in a 1 year methadone-to-abstinence treatment plan. Subjects will be randomized to receive either quetiapine or placebo in addition to ongoing drug addiction treatment. Subjects will be followed for 16 weeks and a variety of psychometric assessments will be made. Hypothesis One: Compared to placebo, Quetiapine will demonstrate a greater reduction in symptoms of anxiety in subjects with GAD and remitted comorbid opiate abuse. Exploratory Hypotheses: Compared to placebo, Quetiapine will demonstrate a greater improvement in psychosocial functioning and compliance with community norms in subjects enrolled in a residential drug addiction treatment facility.

COMPLETED
Optimizing Outcomes Using Suboxone for Opiate Dependence
Description

Building on a platform of pharmacological treatment with Suboxone (buprenorphine and naloxone), participants are randomly assigned to one of four psychosocial treatment conditions.

COMPLETED
Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1
Description

The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES: 1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy. 2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.

COMPLETED
Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1
Description

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

COMPLETED
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
Description

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

COMPLETED
Buprenorphine Maintenance for Opiate Dependence - 6
Description

The purpose of this study is to determine the efficacy of buprenorphine as a substitution pharmacotherapy for opiate dependence.

COMPLETED
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2
Description

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate dependence treatment.

COMPLETED
Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9
Description

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.

WITHDRAWN
Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder
Description

This study aims to examine whether multiple spaced sessions of intermittent theta-burst transcranial magnetic stimulation (iTBS) induce anti-depressant responses and reduce opiate cravings in adults with opiate use disorder (OUD). Additionally, we hope to identify whether the effectiveness of iTBS is related to changes in functional connectivity between particular brain areas.

TERMINATED
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
Description

This double-blind, randomized, controlled trials will investigate the effect of accelerated, repeated transcranial magnetic stimulation on opiate craving and perceived pain .

COMPLETED
Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
Description

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.

COMPLETED
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
Description

This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of an injectable opiate addiction medication (extended release naltrexone) given before reentry into the community that might help to improve reconnection to healthcare and other support systems, and possibly help reduce recidivism.

COMPLETED
Distress Tolerance and HIV Prevention With XR-NTX Initiation in Opioid Dependence
Description

Before starting treatment with XR-NTX, a medication that blocks the positive effects of opioids and helps people stay off opioids, individuals who are dependent on opioids first have to endure a difficult withdrawal process. This study aims to develop and test an intervention to help people who are opioid dependent successfully complete that transition; the investigators will also develop and test a comparison condition aimed at reducing HIV risk behavior.

COMPLETED
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Description

The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.

COMPLETED
Using mHealth to Aid Opioid Addicts
Description

The purpose of the proposed study is perform focus groups to identify and prioritize features of the SubAID application (APP). The SubAID APP is smartphone APP being created to support patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have difficulty in managing bup/nal in the prescribed manner. Not taking medicines in their prescribed manner can cause negative health outcomes. Focus group participants will be asked to elaborate on medication-taking patterns that work best for them, pitfalls associated with poor adherence and offer opinions upon what features/functions the SubAID APP should perform to be most helpful to them. The focus group is designed to remain open-ended and allow free discussion regarding each particular topic that the moderator will bring up.

COMPLETED
Remote Observed Dosing to Increase Suboxone Compliance
Description

The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).

COMPLETED
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
Description

The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.

COMPLETED
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
Description

The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.

COMPLETED
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
Description

The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

COMPLETED
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Description

This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

COMPLETED
Linking Hospitalized Injection Drug Users to Buprenorphine
Description

This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.

COMPLETED
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Description

The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

COMPLETED
Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China
Description

A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with methadone maintenance treatment in Wuhan, China

COMPLETED
Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
Description

The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.

COMPLETED
Employment-Based Depot Naltrexone Clinical Trial
Description

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

COMPLETED
Employment-Based Depot Naltrexone Clinical Trial II
Description

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.