Treatment Trials

307 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
The Role of the Opioid System in Placebo Effects on Pain and Social Rejection
Description

The current study probes the involvement of the opioid system in placebo effects on social pain, using the opioid antagonist naloxone. 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning. Participants will be randomized to receive either a naloxone or saline nasal spray, and be informed that the spray is either saline, or an effective pain and negative emotion reducing agent.

COMPLETED
Harnessing Placebo Effects in Methadone Treatment
Description

More than 2 million individuals in the United States have an Opioid Use Disorder (OUD). Methadone maintenance treatment is the gold standard of medication-assisted treatment for OUD, but high-dose methadone is associated with cardiotoxicity and respiratory complications, among other side effects. These adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal. Long recognized for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement. This approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution, and may thereby be more sensitive to placebo effects. Our study combines two promising clinical methodologies-open-label placebo and conditioning-to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking OUD patients.

COMPLETED
Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Description

Studies of the neural mechanisms underlying placebo effects in antidepressant clinical trials largely have been limited to demonstrating objective differences in brain activity between responders and non-responders to placebo. This 8 week Placebo-controlled and Open groups study employs a novel antidepressant trial design with integrated functional magnetic resonance imaging (fMRI) to manipulate patient expectancy and examine its neural mediators.

COMPLETED
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Description

Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

WITHDRAWN
Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease
Description

After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will change compared to placebo in patients with chronic angina and peripheral arterial disease.

COMPLETED
Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)
Description

The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects; 1. The effect of receiving blinded placebo, compared to no treatment; and 2. The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Conditions
COMPLETED
Conditioning, the Placebo Effect, and Psoriasis
Description

This study uses the psychological principle known as classical conditioning to try to improve the standard treatment of psoriasis. Classical conditioning is a process of behavioral modification in which a person learns to connect a certain response-in this case, improvement of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream. The goal of this study is to show that people with psoriasis who are maintained on corticosteroid cream part of the time and an inactive (placebo) cream at other times show a lower incidence of relapse and a reduced severity of psoriasis that patients treated with that same (reduced) amount of medication administered all the time.

Conditions
COMPLETED
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
Description

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

NOT_YET_RECRUITING
Context Interventions: Social Modeling and Initial Treatment Experience
Description

In this experiment, the investigators study the brain pathways underlying several promising context interventions that enhance the strength of placebo effects. Specifically, the investigators examine the separate and joint effects of two of the most powerful context interventions: Social modeling-observing someone else being effectively treated-and prior treatment success or failure experiences. Participants will be randomized into 4 groups (Social modeling: observed success vs. observed failure and Conditioning: experienced success vs. experienced failure). The objectives are to investigate the placebo effect on pain relief and aversive image stimuli between and within-subjects. Each group will undergo a behavioral induction phase, fMRI placebo test phase, and an identical 3-month follow up fMRI placebo test phase. Follow-up assessment will provide some of the first evidence on predictors of the durability of placebo and context interventions.

COMPLETED
The Effect of Tablet Size on Cognitive Performance Caffeine
Description

This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine. Participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.

Conditions
COMPLETED
Characterization of Placebo Responses in Stable Asthma
Description

The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. . Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on three different occasions each. At each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved and an 11-point, self-reported scale of improvement are examined.

NOT_YET_RECRUITING
Neural Mechanisms of Interpersonal Expectations on Negative Affect
Description

The goal of this clinical trial is to learn whether non-invasive brain stimulation, called transcranial temporal interference stimulation (tTIS), can reduce negative affect, and how expectations shaped by care providers influence these effects. The main questions this study aims to answer are: (1)Does active tTIS reduce negative affect more effectively than sham (inactive) tTIS? (2)Do positive treatment expectations enhance the effects compared to negative expectations? Participants will: (1) Receive either active or sham tTIS. (2) Be provided with positive or negative messaging regarding treatment effectiveness. (3) Interact with care providers and complete assessments measuring negative affect and physiological responses.

COMPLETED
Non-Specific Effects of Manual Therapy
Description

The mechanism responsible for improvement following manual physical therapy techniques is unknown. Previous studies have indicated both biomechanical and neurophysiologic effects which may be responsible for clinical changes observed. Yet, other studies report clinical changes following sham interventions. Through a mixed-methods design, this study aims to gain more understanding of the social and contextual factors that may be related to the improvement often observed following manual therapy techniques.

COMPLETED
Effects of Open-label vs Double-blind Treatment in IBS
Description

The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.

RECRUITING
Transcranial Direct Current Stimulation and Modulation of Affect and Pain
Description

This double-blind randomized crossover study aims to examine the effects of left primary motor cortex (M1) tDCS on evoked thermal pain perception, pain-related decision making, and placebo effects by manipulated pain and monetary offers accepted by others. The investigators plan to collect data for up to 50 participants who undergo four separate sessions: an initial pain calibration session and three experimental sessions with either anodal, cathodal, or sham tDCS. Each session includes pain testing before and after a single tDCS protocol (either anodal, cathodal, or sham), a pain-monetary decision-making task, and social placebo pain tests. All tasks following tDCS will take place inside the MR scanner. The investigators hypothesize that anodal M1 tDCS will decrease pain ratings, and that cathodal tDCS will increase them, both relative to the sham condition. The investigators will also examine the effects of M1 tDCS on social decision-making to examine whether it affects participants' valuation of pain and their altruistic behavior, as well as how these same factors impact pain sensation in the placebo task. The investigators hypothesize that participants will behave hyperaltruistically during the decision-making task, and that the same factors that influence choice will also impact pain perception in the same context.

RECRUITING
HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
Description

The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. This study will include patients with chronic low back pain. The main question it aims to answer is: How do rationales influence the effects of open-label placebos? Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.

COMPLETED
Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease
Description

A double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.

COMPLETED
Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
Description

Placebo pills (pills with no active ingredients) have been shown in research studies to somehow produce self-healing processes. The purpose of this study is to determine whether people will be willing to enter an open-label non-deceptive placebo treatment for Major Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in the context of a supportive physician-patient relationship.

NOT_YET_RECRUITING
Individual Differences in Placebo Analgesic Effects
Description

This study examines the effects of placebo suggestions tailored to match or mismatch individual participants' motivational styles-an issue of person-situation 'fit' with important effects in public health settings, but which has been ignored in past research.

Conditions
COMPLETED
A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency
Description

The purpose of this study is to evaluate sustained tolerability, quality of life, and change in cognitive efficiency following treatment with OnabotulinumtoxinA and daily topiramate vs. OnabotulinumtoxinA and daily placebo (Group A vs. Group B).

COMPLETED
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
Description

The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.

COMPLETED
Efficacy of Energy Shots and Caffeine for Energy and Wakefulness Levels
Description

The line of "5-hour Energy"® products are available over-the-counter as energy supplements. The appeal of these products involves ease of use, low caloric value, and the absence of sugar to prevent a "crash" later in the day. The definitive efficacy and potency of the products is unknown due to the lack of evidence-based clinical reports. It is suspected that the efficacy related to these products is due to the caffeine content, which was reported as 138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this randomized, double-blind, placebo controlled, four way crossover study is to evaluate the efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, caffeine, and placebo for perceived energy and wakefulness.

TERMINATED
A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients
Description

This is a randomized, multi-center, double-blind, Phase III study of radium-223 plus enzalutamide or darolutamide compared to enzalutamide or darolutamide treatment plus placebo.

COMPLETED
Fish Oil vs. Placebo on Subjective Effects of Alcohol
Description

This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects in healthy social drinkers.

COMPLETED
Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients
Description

The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.

COMPLETED
Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
Description

The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be evaluated.

WITHDRAWN
Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
Description

The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

COMPLETED
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
Description

This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive substance) in preventing restenosis (closure of vessel) within six months after stent implantation. Patients must be enrolled into this study within 24 hours after the stenting procedure. Additionally, over a 1- to 9-month post-stent period, the study will compare the safety and effectiveness of BO-653 versus placebo for measures of coronary artery vessel size by quantitative coronary angiography, major adverse cardiac events, and effects on the oxidative status of plasma lipids and other plasma components.

RECRUITING
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Description

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

RECRUITING
A Placebo-Controlled Study Evaluating the Effects of Arrabina P on Satiety in Healthy Adults
Description

This study is being conducted to assess the effects of a prebiotic product, Arrabina P, on appetite in healthy adults. The goal is to see if this product can help with appetite regulation, support gut health, and support weight management.