45 Clinical Trials for Various Conditions
The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD) and history of past or current evidence of alcohol withdrawal symptoms. If medical detoxification is required for any patient, patients would be enrolled after medical detoxification. for those not requiring detoxification, they will be enrolled directly without any requirement of alcohol abstinence. All patients will be provided behavioral counseling weekly with a trained counselor to support recovery during the trial. Primary outcomes will be percent of subjects no heavy drinking days (PSNHDD) and %of any drinking and heavy drinking days as well as secondary outcomes of craving, mood, anxiety and sleep problems.
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.
Background: - Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment ( spontaneous quitting). Studies have suggested that there are some common strategies that many individuals use in spontaneous quitting, such as changing one s lifestyle or identity, reminding oneself of negative consequences, support from family and friends, and religion. However, more research is needed to determine potential treatment strategies for marijuana use. Objectives: * To identify strategies used to help with marijuana quitting among non-treatment seeking adult marijuana users. * To identify withdrawal symptoms experienced during marijuana quitting and their relationship to the quitting strategies used and the outcome of the quit attempt. * To evaluate whether subgroups of marijuana users differ in their experience of marijuana quitting. Eligibility: - Individuals at least 18 years of age who have made at least one attempt to quit marijuana use. Design: * The study will consist of one visit of approximately 1 to 2 hours. * Participants will fill out three questionnaires. The questionnaires have different types of questions, and will ask about background and lifestyle, marijuana use and craving patterns and behaviors, and difficulties in previous attempts to quit using marijuana.
We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.
The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.
Background: * Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and diarrhea. Many people have these symptoms when trying to stop using opioid drugs. Long-acting opioids like methadone and buprenorphine are used to help people stop using other opioids, but these drugs can cause the same withdrawal symptoms. There are no non-opioid drugs that are approved specifically to treat those symptoms. * Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug allowed heroin users to decrease their methadone dose faster without much discomfort, and stay abstinent from heroin. Researchers want to learn more about how pioglitazone helps treat opioid withdrawal symptoms. Objectives: - To test whether pioglitazone can reduce opioid withdrawal symptoms. Eligibility: - Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid dependency. Design: * This study will last up to 17 weeks. Participants must come to the study clinic every day for at least 13 weeks. * Participants will be screened with a physical exam and medical history. They will also answer questions about drug use habits, and provide blood and urine samples. * Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose will be increased to a level that should help stop the use of opioids. For the next 4 weeks, the dose will be decreased. Blood, urine, and breath samples will be collected at different study visits. Participants will also fill out questionnaires about mood, drug craving, and withdrawal symptoms. * After 1 week on buprenorphine, participants will start the study pill (pioglitazone or a placebo) every day. They will take the study pill for 13 weeks. * During the treatment period, participants will have drug counseling once a week for 30 minutes. * Some participants have other tests as part of this study. These tests include functional magnetic resonance imaging scans to look for changes in brain activity and giving samples of cerebrospinal fluid to study brain chemistry. * Participants will have a final followup phone call 3 weeks after the last clinic visit.
Background: - Smoking is thought to cause changes in the brain that lead to addiction and craving. Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop smoking. Many people say that they continue smoking to help relieve these symptoms, often within the first week after trying to quit. Researchers want to study what is happening in the brain to cause these symptoms, which may help identify new ways to successfully quit smoking. Objectives: - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36 hours. Eligibility: - Individuals between 18 and 65 years of age who smoke at least 10 cigarettes per day. Participants must be able to stop smoking for 36 hours on two occasions. Design: Phase 1 * This study will involve three visits to the National Institute on Drug Abuse. * NOT be able to smoke for 36 hours before the two imaging visits. * Wear a nicotine skin patch or a placebo (fake) patch during your 36 hour smoking abstinence period and study visits. * Have your blood drawn to test for levels of stress-related hormones. * Complete multiple MRI scanning sessions that last about 1.5 to 2 hours each. * Undergo EEG (brain waves) recording. * Answer questionnaires about how you think and feel. * Complete various tasks and procedures inside and outside of the MRI scanner. Phase 2 * This study will involve thirteen visits to the National Institute on Drug Abuse. * Set a quit date and develop a treatment plan with a study therapist. * Take Chantix (varenicline) every day for a period of 12 weeks. * Meet for weekly and biweekly counseling sessions with a therapist. * Answer questionnaires about how you think and feel. Phase 3 * This study will involve three visits to the National Institute on Drug Abuse. * Complete an MRI scanning session that will last about 20min each visit * Meet with a study staff member on each visit who will ask you questions about your smoking behavior and how you think and feel.
This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include assessing whether these agents relieve craving for cigarettes elicited by exposure to a mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and placebo will be administered one at each of the three sessions in a randomized order.
We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.
Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy.
Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.
Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification.
This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and have a follow-up call 1-3 months after their inpatient stay. Participants will complete several psychiatric questionnaires/interviews, physiological monitoring with several devices, brain imaging, and VNS testing.
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase (including a methadone stabilization period, a placebo administration period, a treatment administration period and a safety/washout period), and a Follow-up Phase.
Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic treatment; those infants born to mothers with co-dependence on an opiate and a benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe in this population. If it is safe, we can include these infants in the large double blind, double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other hand, these infants have respiratory depression or other adverse events when buprenorphine is given, it will be important to report this study and caution the use of buprenorphine in these infants
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.
Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly brain stimulation system that increased 6-month treatment retention of OUDs in a pilot study; and also, acutely reduced opioid withdrawal severity and negative affect during induction into opioid maintenance therapy. This study will establish its effectiveness in a broad category of OUD subjects at different stages of OUD care continuum.
The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance. The opioid (morphine) maintenance phase (Phase 1b) included Days 1-5; the randomized BXCL501/placebo phase (Phase 2) included Days 6-12. The randomized phase was followed by 2 sequential days, Days 13 and 14, utilizing treatment of BXCL501-placebo sublingual films and morphine-placebo capsules for all subjects who remained in the study.
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
Individuals recovering from drug and/or alcohol addiction initially experience the symptoms of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS include a wide array of emotional and psychological symptoms such as anxiety, sleep disturbances, depression, and stress. Previous studies have shown that melatonin therapy was beneficial to alleviate anxiety, depressive symptoms, and sleep disturbances. However, no randomized, double-blind, placebo controlled trials have been conducted in males who are experiencing PAWS. The purpose of this study is to investigate the effect of 5 mg melatonin given nightly for four weeks on weekly assessed, self-reported anxiety, depressive symptoms, insomnia, and stress in males with PAWS who reside in a residential treatment center.
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During the first 3-days of each treatment period, smokers will have daily clinic visits, where they will receive study medications and any adverse effects from study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the experimental session on Day 4. Compliance with non-smoking will be verified by CO levels \< 10 ppm. During the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine treatments, physiological, subjective and cognitive measurements will be obtained
The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals.
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2) nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week intensive post-treatment follow-up. In addition, 20 percent of the subjects will be randomized to a delayed-quit control group.