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Opioid System's Role in Placebo Effects for Pain
Study Summary
This trial is investigating whether the opioid system is involved in the placebo effect of social pain relief. 60 participants who have recently experienced an unwanted breakup will be exposed to rejection-related stimuli and given painful heat and pressure stimuli during fMRI scanning. They will be randomized to receive either a naloxone or saline nasal spray, and be told that the spray is either saline or an effective pain and negative emotion reducing agent.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am currently experiencing pain.You have a history of using drugs or alcohol in a way that caused problems or dependence.I do not have ongoing or recent severe pain or neurological disorders.You are afraid or uncomfortable in small, enclosed spaces.My blood pressure is not stable.I can read and cooperate with an fMRI exam.You recently went through a tough breakup with your romantic partner.You currently have or have had a mental health condition in the past.I suffer from long-term pain.I have had a stroke or mini-strokes before.I have a neuroendocrine disorder like Cushing's disease.I have a condition like multiple sclerosis affecting my brain or spinal cord.I do not have a psychiatric or major neurological condition.I have a condition related to inflammation of the blood vessels in my brain, or an autoimmune disease.I have had a head injury that made me lose consciousness.I haven't taken antidepressants, mood stabilizers, steroids, or opiates in the last month.I am between 18 and 55 years old.You have not consumed alcohol or used any drugs for the past 48 hours.I have a tumor or mass in my body.I have not had a heart attack or severe heart disease in the last two years.I have or had cancer.My thyroid condition is not being treated.You have a type of memory loss and cognitive decline known as dementia.I do not have a brain infection.I have a seizure disorder.I have metal in my body or have worked with metal fragments.I am not pregnant.I am fluent in English.I have a movement disorder that is not familial tremor.You were born with a brain condition like cerebral palsy.I have taken antipsychotics, isoniazid, or certain blood pressure medicines.I have been diagnosed with chronic fatigue syndrome.
- Group 1: Saline Group
- Group 2: Naloxone Group
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial recruiting participants currently?
"According to the clinicaltrials.gov site, this investigation is not presently recruiting participants, though it was initially listed on September 1st 2023 and most recently edited on October 25th 2022. However, there are 382 other trials across multiple sites that are currently seeking patients."
Is eligibility for participation in the trial limited to individuals over 25 years old?
"Those that wish to take part in this clinical trial must have reached the age of majority and not yet exceeded 55 years."
Could you provide a synopsis of prior experiments involving Control Cream with Naloxone?
"Presently, the Control Cream with Naloxone has achieved Phase 3 in 9 distinct clinical trials. The majority of these are being conducted at Durham, North carolina; however, 119 other medical sites around USA are also participating in research for this medication."
What is the population size of participants involved in this experiment?
"As of the last update on October 25th 2022, this research trial is not actively recruiting subjects. If you are still in search of a medical study to participate in, there are presently 344 clinical trials seeking patients related to placebo effect and 38 studies requiring volunteers for Control Cream with Naloxone."
Who qualifies to enroll in this clinical research?
"Patients between the ages of eighteen and fifty-five who have a placebo effect are eligible to take part in this clinical trial. Around sixty participants will be selected."
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