Naltrexone for Social Connection
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take 50mg of naltrexone or placebo once a day for 7 days and complete daily reports on social connection and mood.
Neuroimaging
On the 7th day, participants undergo fMRI scanning to complete tasks designed to elicit feelings of social connection.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Naltrexone Hydrochloride
- Placebo
Naltrexone Hydrochloride is already approved in United States, European Union for the following indications:
- Alcohol use disorder
- Opioid use disorder
- Alcohol use disorder
- Opioid use disorder
- Alcohol use disorder
- Opioid use disorder
- Alcohol dependence
- Opioid dependence
Find a Clinic Near You
Who Is Running the Clinical Trial?
San Diego State University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator