210 Participants Needed

Naltrexone for Social Connection

TI
Overseen ByTristen Inagaki, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: San Diego State University

Trial Summary

Do I have to stop taking my current medications to join the trial?

Yes, you must stop taking your current medications. The trial excludes people who regularly use prescription medication.

What data supports the idea that the drug Naltrexone for Social Connection is an effective treatment?

The available research shows that Naltrexone, particularly in its long-acting injectable form, has been effective in reducing heavy drinking and promoting abstinence in people with alcohol dependence. Studies have found that these formulations help maintain consistent drug levels in the body, which can reduce side effects and improve treatment outcomes. However, the effectiveness of Naltrexone can vary based on patient adherence to the treatment plan. While the drug is primarily used for alcohol and opioid dependence, the data suggests it can be a useful part of a treatment plan for those who are motivated and have strong support systems.12345

What safety data exists for naltrexone treatment?

Naltrexone, available in oral and injectable forms (ReVia, Vivitrol, Depade), has been studied for alcohol and opioid dependence. Oral naltrexone can cause adverse events and plasma level fluctuations, while injectable forms like Vivitrol have a less severe adverse-event profile. Injectable extended-release naltrexone has been evaluated for long-term safety and efficacy in opioid dependence, with concerns about rebound overdose risk after the last dose. Preclinical studies show that naltrexone and its polymer matrix are well tolerated. Further studies are needed to fully understand the safety and efficacy of different formulations.12367

Is the drug Naltrexone Hydrochloride a promising treatment for social connection?

Naltrexone Hydrochloride shows promise as it can help reduce cravings and prevent relapse in people with alcohol and opioid dependence. It has been effective in increasing the time to first relapse in some patients and has potential benefits in reducing HIV risk among opioid users. Extended-release forms improve patient compliance, making it a promising option.128910

What is the purpose of this trial?

The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.

Research Team

TI

Tristen Inagaki, PhD

Principal Investigator

San Diego State University

Eligibility Criteria

This trial is for English-speaking individuals in good health who are willing to share contact info of close friends, provide photos of loved ones, own a smartphone, and aren't pregnant. It's not for those with BMI over 35, metal implants, claustrophobia, regular prescription medication use, positive drug tests or excessive alcohol use.

Inclusion Criteria

I am in good health overall.
Willing to provide digital photographs of 2 close others
English fluency
See 2 more

Exclusion Criteria

Previous history of having difficulty taking pills
Depressive symptoms above a 9 on Patient Health Questionnaire
Self-reported chronic mental or physical illness
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take 50mg of naltrexone or placebo once a day for 7 days and complete daily reports on social connection and mood.

1 week
7 daily reports (virtual), 1 visit (in-person)

Neuroimaging

On the 7th day, participants undergo fMRI scanning to complete tasks designed to elicit feelings of social connection.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

  • Naltrexone Hydrochloride
  • Placebo
Trial Overview The study examines the effects of naltrexone (an opioid blocker) on social connection feelings compared to a placebo. Participants take either naltrexone or placebo daily for a week and report their mood and social experiences. On the last day, they undergo an MRI scan while performing tasks that evoke social feelings.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NaltrexoneExperimental Treatment1 Intervention
50mg naltrexone HCL once daily for seven days by mouth
Group II: placeboPlacebo Group1 Intervention
sugar pill once daily for seven days by mouth

Naltrexone Hydrochloride is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as ReVia for:
  • Alcohol use disorder
  • Opioid use disorder
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Vivitrol for:
  • Alcohol use disorder
  • Opioid use disorder
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Depade for:
  • Alcohol use disorder
  • Opioid use disorder
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Naltrexone for:
  • Alcohol dependence
  • Opioid dependence

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials
182
Recruited
119,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

A systematic review of 49 trials found that only 14% of studies on naltrexone for alcohol dependence had high adherence assurance, which may explain the variability in treatment efficacy observed.
The study revealed a significant correlation between adherence levels and treatment outcomes, suggesting that improving adherence monitoring could enhance the effectiveness of naltrexone in clinical settings.
Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review.Swift, R., Oslin, DW., Alexander, M., et al.[2022]
Injectable extended-release naltrexone, developed using biodegradable polymer microspheres, maintains stable plasma levels for about one month after a single injection, which could improve patient compliance compared to oral formulations.
Pharmacokinetic studies in rats and monkeys showed that this formulation effectively antagonizes morphine analgesia without affecting the brain's mu-opioid receptor density, indicating its potential safety and efficacy in treating alcohol and opioid dependence.
The preclinical development of Medisorb Naltrexone, a once a month long acting injection, for the treatment of alcohol dependence.Dean, RL.[2019]
Injectable formulations of naltrexone, such as Vivitrex/Vivitrol and Naltrel, show promise in treating alcohol dependence with potentially fewer side effects compared to oral naltrexone, which has limitations like a small treatment effect size and plasma level fluctuations.
Vivitrex/Vivitrol has been effective in reducing heavy drinking in alcohol-dependent males, while Naltrel has been shown to promote abstinence and reduce relapse rates, indicating that these depot formulations may offer improved therapeutic options for alcohol dependence.
Naltrexone long-acting formulation in the treatment of alcohol dependence.Johnson, BA.[2021]

References

Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. [2022]
The preclinical development of Medisorb Naltrexone, a once a month long acting injection, for the treatment of alcohol dependence. [2019]
Naltrexone long-acting formulation in the treatment of alcohol dependence. [2021]
Naltrexone: a controversial therapy for alcohol dependence. [2022]
Review of naltrexone, a long-acting opiate antagonist. [2013]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy]. [2016]
Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence. [2019]
Antagonist Models for Relapse Prevention and Reducing HIV Risk. [2018]
Cloninger's typology and treatment outcome in alcohol-dependent subjects during pharmacotherapy with naltrexone. [2022]
Crystal structure of naltrexone chloride solvates with ethanol, propan-2-ol, and 2-methyl-propan-2-ol. [2020]
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