Naltrexone Hydrochloride for Naltrexone

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
San Diego State University, San Diego, CA
Naltrexone+1 More
Naltrexone Hydrochloride - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether naltrexone can reduce the effects of oxytocin on social connection.

See full description

Eligible Conditions

  • Naltrexone
  • Placebos

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Naltrexone Hydrochloride will improve 3 primary outcomes and 1 secondary outcome in patients with Naltrexone. Measurement will happen over the course of post-treatment, change across 7 days.

Day 7
feelings in response to neuroimaging tasks
Day 7
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
Day 1
physical symptoms via daily diary
Day 7
Daily feelings of social connection via ecological momentary assessment

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Naltrexone
1 of 2
placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 210 total participants across 2 different treatment groups

This trial involves 2 different treatments. Naltrexone Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Naltrexone
Drug
50mg naltrexone HCL once daily for seven days by mouth
placebo
Drug
sugar pill once daily for seven days by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 7, approximately 60 mins after taking study drug
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 7, approximately 60 mins after taking study drug for reporting.

Who is running the study

Principal Investigator
T. I.
Prof. Tristen Inagaki, Assistant Professor
San Diego State University

Closest Location

San Diego State University - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
good health
English fluency
willing to provide contact information for 4-6 close others
willing to provide digital photographs of 2 close others
own a smartphone

Patient Q&A Section

How many people get placebos a year in the United States?

"Although the number of people receiving placebos was small (about 1 in 20,000), this was nearly double the number receiving placebo; this suggests that people are seeking treatment for conditions that were diagnosed on the basis of placebo-associated effects. Recent findings underscore the importance of conducting well-designed, placebo-controlled trials." - Anonymous Online Contributor

Unverified Answer

What causes placebos?

"There are many reasons for placebo responses. Possible reasons for placebo effects might include: (1) a form of the no-drug effect; (2) placebo effect due to expectation; (3) self-focusing in the expectation of a cure; or (4) the placebo effect due to cognitive dissonence (which is similar to the no-drug effect)." - Anonymous Online Contributor

Unverified Answer

Can placebos be cured?

"Since we used a placebo, the placebo effect appears to be a major contributor to the remission observed at the end of the 4-week trial in our study." - Anonymous Online Contributor

Unverified Answer

What is placebos?

"The use of placebos reduces patient response rates substantially. It is important that the patients acknowledge all the possibilities of nonpharmacological interventions for their pain and that the clinical research community is very conscious of placebos." - Anonymous Online Contributor

Unverified Answer

What are the signs of placebos?

"When all possible placebo effects for the active drug and the active drug and placebo were combined, the actual number of patients would decrease by about 60 percent. If more than 25 percent of patients are not receiving the active drug, many patients will not have enough of a placebo effect to produce benefit. Since the benefits of the placebo effect are difficult to measure in clinical trials, there is no way to eliminate placebo effects." - Anonymous Online Contributor

Unverified Answer

What are common treatments for placebos?

"Many drugs and therapeutic regimens were commonly administered to patients with placebos. The common treatments should be more strictly controlled and standardized. A placebo should be used in all trials if any new treatment is to receive regulatory approval in China." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for placebos?

"Because of the significant number of potentially placebo responders, clinicians should consider clinical trials for placebos in their practice (and not just with patients who could benefit from placebo-based therapy). This article is protected by copyright. All rights reserved." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in naltrexone hydrochloride for therapeutic use?

"Naltrexone HCL has been shown to be safe and effective in the palliative treatment of opioid-induced constipation and is being investigated as a potential medication for the prevention of opioid-related side effects in chronic pain patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for placebos?

"No clinical trials are currently comparing the effectiveness of placebo with antiemetic agents or SSRIs in treating nausea and vomiting associated with cancer chemotherapy. Although this type of research is needed, many drugs have demonstrated efficacy in non-cancer settings—that is, the drugs in question have shown some efficacy in treating nausea and/or emesis with or without chemotherapy." - Anonymous Online Contributor

Unverified Answer

How serious can placebos be?

"This review of a large number of literature reviews of the placebo effect in medicine has found a substantial variation in the reported frequency of the effect. The reviews suggest that the effects of placebos vary widely depending not only on how often the term 'placebo' is used, but also on its definition." - Anonymous Online Contributor

Unverified Answer

Does naltrexone hydrochloride improve quality of life for those with placebos?

"Placebo is an effective pharmacologic intervention for improving the quality of life in both clinical and nonclinical populations. Use of naltrexone for 3 months resulted in a significant improvement in global QoL and fatigue for those on placebo, as well as for participants on naltrexone plus placebo. These data support the use of naltrexone as an adjunct to treatment for opioid dependence." - Anonymous Online Contributor

Unverified Answer

What is naltrexone hydrochloride?

"The clinical trial that included subjects and control subjects, and the two trials that excluded subjects and control subjects, are not statistically equivalent in their potential for bias. Therefore, any clinical trial results that included subjects and control subjects are valid, and their conclusions may be applicable." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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