View clinical trials related to Opioid-Related Disorders.
Filter by: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 .
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.
The study is 12-week, randomized, open-label study comparing injectable extended-release buprenorphine (Sublocade) to standard therapy (sublingual buprenorphine), to see if Sublocade will be more helpful in treating opiate use for individuals testing positive for fentanyl and related high potency drugs (HPSO). Those receiving Sublocade will have it administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the first and second dose and 100mg for the third. Individuals receiving sublingual buprenorphine will receive standard dosing for the entire treatment trial. Participants will be asked to attend the clinic for the first 4 days during week 1 and twice weekly for the remainder of the trial.
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.
Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. Investigators will compare an active and a sham treatment given twice weekly for 4-weeks. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.
The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based on safety) rather than approved (based on efficacy), which means the BD did not need to demonstrate efficacy before it became commercially available. As a result, the device was not required to have a sham-controlled trial for FDA clearance and there is no active research, to the investigators' knowledge, that specifically addresses the degree to which opioid withdrawal can be treated through neuromodulation. To rigorously evaluate the efficacy of the BD for treating OUD, the investigators will enroll persons with active OUD, not currently receiving medications for OUD. Participants will be recruited and admitted to the Clinical Research Unit (CRU) for a 2-3 week period. During participants' residential stay, participants will be stabilized for 7-11 days on four times daily morphine (30 mg, SC) and undergo a precipitated withdrawal challenge using the opioid antagonist naloxone, approximately >= 4 days of morphine maintenance. This is a standard practice for the investigators' study and allows the investigators to objectively assess dependence. The BD and study medication will begin following morphine stabilization. Participants will be randomly assigned to one of three conditions (1) active BD with placebo (BD/P), (2) sham BD with lofexidine (SBD/L), or (3) sham BD and placebo (SBD/P). Participants will use the BD for 5 days and will receive study drug for 7 days. Participants will be monitored for an additional 4 days after device removal to determine whether withdrawal resumes. Participants will undergo a second naloxone challenge after removal of the device/capsule completion to verify lack of opioid tolerance and will be encouraged to begin treatment with oral naltrexone followed by extended release naltrexone. Throughout the residential stay, all participants will be given referral to and assisted with engaging in outpatient treatment following study discharge.
Evidence from recent trials primarily in the post-surgical patient population prescribed opioids for acute pain suggest patients more often properly dispose of unused opioids if instructed by a healthcare professional, if provided education on proper storage and disposal, and provided a physical medication disposal product (e.g. mail back bags). It is not clear how this evidence applied to patients in primary care will be readily adopted and sustained by practices and if the effectiveness will be comparable to that seen in other more controlled studies, largely limited to the surgical population. The objective of this trial is to evaluate a multifaceted program for safe medication disposal in primary care. Interventions include real-time best practice reminders to providers, educational materials mailed to patients, disposal mail-back bags supplied to patients and reminder phone calls. Proper medication disposal after 30 days following order will be assessed by telephone survey. Our aims are to: 1. Evaluate a targeted intervention on patient's newly prescribed opioids within primary care. 2. Determine factors that influence patient action to remove unused opioid medications from the home.
Background: People with opioid-use disorder (OUD) might benefit from having more treatment drugs to choose from. A new drug, TRV734, could be used like methadone to treat OUD. It might not have as many side effects. Objective: To test if TRV734 relieves withdrawal symptoms and has fewer side effects than oxycodone in people with OUD. Eligibility: People ages 18-75 who have been receiving daily treatment with methadone for opioid use disorder for at least 3 months Design: Participants will be screened under Protocol 415. They will be screened with: Medical, social, and psychiatric history Physical exam Electrocardiogram (ECG). For this, sticky pads will be placed on the participant s chest to monitor their heartbeat. Blood and urine tests Participants will stay in a residential unit for 13-21 days. Most days, participants will receive their regular daily dose of methadone. On 4 or 5 occasions, 3-4 days apart, participants will skip two doses of methadone in a row. About 4 hours after they skip the second dose, they will have an IV catheter inserted with a needle so that blood samples can be taken. They will take capsules of either oxycodone, a placebo, or the study drug. They will have an ECG. They will complete questionnaires. Their blood pressure, pupil size, and alertness will be tested. They will then take their usual dose of methadone. Participants will give daily urine and breath samples.
Despite high prevalence, few hospitalized inpatients with opioid or alcohol use disorders (OAUDs) receive evidence-based treatments while in the hospital or get linked with appropriate follow-up care, leading to poor clinical outcomes and high readmission rates and costs. The purpose of this study is to evaluate whether a physician and care manager with addiction expertise, both members of the Substance Abuse Treatment and Recovery Team (START), can help improve initiation of treatment in the hospital and linkage to follow-up care upon discharge. START members have expertise in the treatment of substance use disorders. START will work with the medical or surgical team to ensure appropriate care is received. That care will include therapy, focused discharge planning, and medication treatment options. START will also help establish a follow-up plan for continuation of treatment after hospital discharge. To assess feasibility, the study will enroll 80 patients admitted to the hospital over 5 months in a pilot randomized clinical trial and collect baseline and 1-month follow-up data. To determine acceptability, the study will conduct semi-structured interviews with 40 providers. Results of this pilot study will inform a larger clinical trial.