Amisulpride for Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether amisulpride, an antipsychotic medication, can alter feelings about drugs like fentanyl during medical procedures. The focus is on whether amisulpride affects how much someone "likes" the drug effects. Participants will receive either amisulpride or a placebo before their procedure. The trial seeks individuals scheduled for surgery who will receive fentanyl and do not have lung or heart issues requiring special treatment or recent use of certain medications. As an Early Phase 1 trial, this research aims to understand how amisulpride works in people, offering participants a chance to contribute to groundbreaking medical knowledge.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking certain medications, including amisulpride, droperidol, levodopa, lithium, clozapine, metoclopramide, benzodiazepines, and opioids, to participate in this trial.
Is there any evidence suggesting that Amisulpride is likely to be safe for humans?
Research shows that amisulpride is generally well-tolerated in various situations. One study found that people taking amisulpride experienced similar safety and tolerability compared to other forms of the medication. Past studies have reported common side effects such as increased appetite, weight gain, and drowsiness. For most people, these effects were mild.
Amisulpride is already used in some treatments, providing some confidence about its safety. However, since this study is in the early stages, the researchers are still gathering detailed safety information specific to addiction treatment.12345Why do researchers think this study treatment might be promising?
Amisulpride is unique because it targets dopamine receptors differently than typical treatments for addiction, which often focus on opioid receptors or behavioral therapies. While most traditional addiction treatments like methadone or buprenorphine are opioid-based, Amisulpride is an antipsychotic that works by modulating dopamine, a neurotransmitter involved in reward and pleasure pathways. This novel mechanism of action offers a fresh approach, potentially reducing cravings and withdrawal symptoms without the dependency risks associated with opioids. Researchers are excited about its potential to provide a safer and possibly more effective treatment option for those struggling with addiction.
What evidence suggests that Amisulpride might be an effective treatment for addiction?
Research has shown that amisulpride might help people struggling with addiction. Studies have found that individuals using amisulpride for various addictive substances experienced improvements, potentially reducing the urge or desire to use drugs. The medication appears effective even for those addicted to multiple substances. While these results are encouraging, this trial continues to study the treatment to confirm its effectiveness for addiction. Participants in this trial will receive either amisulpride or a placebo before fentanyl administration for their procedure.16789
Are You a Good Fit for This Trial?
This trial is for individuals with an ASA physical status of I, II, or III who are scheduled for surgery or a procedure where they will receive up to 3 mcg/kg IBW of fentanyl. It's not specified who can't join the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug or placebo prior to fentanyl administration before their procedure
Monitoring
Participants are monitored for changes in drug liking and sedation ratings, as well as EEG band power
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amisulpride
Trial Overview
The study is testing whether Amisulpride, compared to a placebo, affects how much patients like the drugs they're given during and after surgery. The goal is to understand if this medication can influence drug liking in a clinical setting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive study drug prior to fentanyl administration before their procedure.
Participants receive placebo prior to fentanyl administration before their procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Citations
Does drug use affect the efficacy of amisulpride, ...
The current study showed that drug use does not appear to affect the overall effectiveness of amisulpride, aripiprazole and olanzapine in patients with SSD.
Does drug use affect the efficacy of amisulpride ...
The current study showed that drug use does not appear to affect the overall effectiveness of amisulpride, aripiprazole and olanzapine in patients with SSD.
Treatment With Amisulpride of Addicted Patients to ...
Conclusion: Treatment with Amisulpride seems to be effective in patients who are on different addictive substances, and its associated morbidity, both at a ...
Treatment with amisulpride of addicted patients to ...
According to the report of the Spanish Observatory on Drugs1 in the year. 2005, 50,630 subjects were admitted to treatment, 46.9% of these due to cocaine, 36.8% ...
5.
semanticscholar.org
semanticscholar.org/paper/Treatment-with-amisulpride-of-addicted-patients-to-M%C3%A1%C3%B1ez-Mu%C3%B1oz/19bfaa46637a7d18ea303d26ed4780519d4c510cTreatment with amisulpride of addicted patients to ...
Treatment with Amisulpride seems to be effective in patients who are on different addictive substances, and its associated morbidity, both at a short and a ...
Bioequivalence and Safety of Two Amisulpride ...
The test and reference amisulpride formulations were bioequivalent under fasting and fed conditions. Both formulations showed similar safety and tolerability.
7.
journals.sagepub.com
journals.sagepub.com/doi/10.1089/cap.2024.0139?icid=int.sj-full-text.similar-articles.1The Safety and Clinical Effects of Amisulpride in Children ...
Results: Amisulpride appeared to reduce psychotic and behavioral symptoms. Observed side effects included increased appetite, weight gain, sedation, and mild ...
Study Details | NCT05956600 | An Open-Label, Single-Arm ...
The objectives of this study are to evaluate the safety and efficacy of Amisulpride as an add-on therapy or alternative monotherapy in treating patients with ...
9.
researchgate.net
researchgate.net/publication/389070026_The_Safety_and_Clinical_Effects_of_Amisulpride_in_Children_and_Adolescents_with_Psychiatric_Disorders_A_Case_SeriesThe Safety and Clinical Effects of Amisulpride in Children ...
Conclusion: Amisulpride may have promise for study and future use in children and adolescents with psychiatric disorders and severe symptoms.
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