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Neurotransmitter
Arginine vasopressin for Acute Pain
Phase 1 & 2
Recruiting
Led By Luana Colloca, MD/PHD/MS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2, the average of 24 trials of painful stimulations with each stimulation lasting 20 seconds
Awards & highlights
Study Summary
This trial investigates how the neurotransmitter vasopressin influences the perception of pain through observational learning.
Who is the study for?
This trial is for English-speaking adults aged 18-55 who experience acute pain. It's designed to understand how a neurotransmitter involved in social interactions, vasopressin, affects learning about pain relief from watching others and how this influences personal pain perception.Check my eligibility
What is being tested?
Participants will receive either vasopressin or saline via nasal spray. They'll then watch videos showing others experiencing pain relief during an fMRI scan to see if observing these scenarios can influence their own sensation of pain through learned expectations.See study design
What are the potential side effects?
Potential side effects may include discomfort from the nasal spray or reactions at the administration site. The fMRI procedure is non-invasive but may cause feelings of claustrophobia or discomfort due to loud noises during scanning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 2, the average of 24 trials of painful stimulations with each stimulation lasting 20 seconds
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2, the average of 24 trials of painful stimulations with each stimulation lasting 20 seconds
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in BOLD Singal in Supplementary Motor Area Compared to Whole Brain Average During the Painful Stimulation
Secondary outcome measures
Heating Temperature
Pain Ratings
Other outcome measures
Implicit Association Test (IAT) Response Latency Difference
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arginine vasopressinExperimental Treatment3 Interventions
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
Group II: SalinePlacebo Group3 Interventions
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arginine vasopressin
2008
Completed Phase 3
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
689 Previous Clinical Trials
374,596 Total Patients Enrolled
4 Trials studying Acute Pain
470 Patients Enrolled for Acute Pain
Luana Colloca, MD/PHD/MSPrincipal InvestigatorUniversity of Maryland Baltimore School of Nursing
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Acute Pain
3 Patients Enrolled for Acute Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals above the age of 35 being actively sought after for enrollment in this medical study?
"Prospective participants must be at least 18 years old and no older than 65 to qualify for this study."
Answered by AI
What is the total number of participants being recruited for this clinical investigation?
"Yes, data on clinicaltrials.gov confirms the active recruitment status of this trial. Initially posted on September 17th, 2018, and last updated on February 27th, 2024. The study aims to recruit 90 patients from a single site."
Answered by AI
What are the specific criteria that determine if an individual is eligible to participate in this research study?
"The clinical trial is open to enrolling 90 individuals experiencing acute pain aged between 18 and 65. Vital requirements include proficiency in written and spoken English and an age falling within the range of 18-55 years old."
Answered by AI
Is the recruitment phase still ongoing for participants in this medical study?
"As per the details on clinicaltrials.gov, this study is currently in search of eligible candidates. The trial's initial posting date was 17th September 2018, with the most recent update noted on 27th February 2024."
Answered by AI
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