Active clinical trials for "Opioid-Related Disorders"

This is a research study of an interdisciplinary pain management program for U.S. military veterans who served during the post-9/11 combat eras (e.g., Operations Iraqi Freedom [OIF], Enduring Freedom [OEF], New Dawn [OND]) presenting with chronic musculoskeletal pain related to military service with comorbid depression and/or posttraumatic stress disorder [PTSD] symptoms and/or mild traumatic brain injury. This study will test the efficacy of an interdisciplinary pain program compared to treatment as usual in the Veterans Health Administration on pain-related disability, opioid medication use, and pain coping.

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.

Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence, current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an alarming number of clinics have extensive waitlists for treatment slots. Patients can remain on these waitlists for years, placing them at elevated risk for illicit drug use, criminal activity, infectious disease, overdose and mortality during this period. These delays in treatment access represent a significant barrier to the widespread delivery of effective opioid treatment, and there is a critical need to develop creative new approaches for mitigating these delays. Our overarching goal in this application is to develop a novel Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our integrative treatment package includes five key components, each strategically chosen to maximize patient access to pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth clinical support delivered via Interactive Voice Response, Automated random call-backs for urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants who have not entered treatment by Week 12 will be offered the opportunity to cross over to IBT at that time, contributing additional within-subject data with which to evaluate the efficacy of the IBT intervention. The proposed research is innovative in several important ways: By facilitating the eradication of waitlists for opioid treatment, it represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment of opioid dependence is conceptualized and delivered. The IBT components are highly novel, both individually and as an integrative interim treatment package for opioid dependence. This study will be the first to investigate the utility of IBT in the patients and settings that stand to benefit most from it. The investigators also propose a multi-pronged dissemination approach that will ensure that our work is readily transported to clinical practice and will have a direct impact on real-world treatment of opioid dependence. Taken together, the proposed project will produce a highly innovative technology-assisted pharmacotherapy protocol that can be widely disseminated to increase access to life-saving opioid treatment. The overarching and specific aims of this proposal are directly relevant to NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse treatment.

The high rate of adverse events, including overdose, resulting from opioid pain medication use threatens the quality and safety of pain care in the Veterans Health Administration (VHA) and elsewhere and is a critical public health problem in the United States. Pain is a highly common condition among VHA patients, and opioid therapy constitutes a primary mode of pain treatment. This study seeks to address this issue by conducting a randomized controlled trial of a brief conversation to improve opioid safety among Veteran patients receiving long-term opioid therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and randomized to receive either a single session motivational intervention focused on safe opioid use or an equal attention control condition. The primary hypothesis is that the motivational intervention will improve opioid safety, decrease risk behaviors, aberrant opioid use, and total quantities of opioids prescribed relative to the control condition. Study findings will inform efforts to ensure the safety and well-being of Veteran patients with pain.

This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at least 6 months of buprenorphine treatment and do not wish to remain in a long--term buprenorphine maintenance program will be recruited. The first phase includes a 4--week period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that patients are stable, compliant, and free from illicit opioids. Participants that meet the above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a gradual 5-week long taper. In both groups participants will receive weekly relapse prevention therapy and will be monitored for the duration of the trial, which is 25 weeks post randomization.

The main purpose of this pilot study is to investigate the safety, effectiveness and tolerability of the study medication in the treatment of people with chronic hepatitis C virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction treatment.

The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

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.

The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT. Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo. Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo. Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.

The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two types of opioid addiction treatment, on the ability to think and reason among people addicted to opiates, and who are either HIV negative or HIV positive; and (2) investigate whether HIV infection changes the way opioid treatment affects the ability to think and reason. The investigators hypothesize that there will be (1) significant improvement in thinking and reasoning ability after starting buprenorphine treatment compared to methadone treatment, among participants with and without HIV at 2 and 4 months compared to baseline; and (2) HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 2 and 4 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants.