Gabapentin + Oxycodone for Recreational Opioid Use
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the potential for abuse of gabapentin, a medication sometimes used to treat nerve pain, when taken alone or with oxycodone, a common opioid painkiller. Researchers aim to understand how these medications affect individuals who use opioids recreationally, meaning for non-medical purposes. Participants will take either gabapentin, oxycodone, both together, or a placebo (a harmless pill with no active ingredients). Individuals who have used opioids recreationally at least ten times in the past year, but are not dependent on them, may be suitable for this trial. As a Phase 4 trial, this research seeks to understand how the FDA-approved treatment benefits a broader patient population.
What is the safety track record for gabapentin and oxycodone?
Research has shown that gabapentin and oxycodone each present safety concerns. Studies have found that combining gabapentin and oxycodone can significantly increase the risk of serious issues, such as breathing problems and overdose. Gabapentin is often misused, and when combined with opioids like oxycodone, the risks can escalate.
Oxycodone alone, like other opioids, can cause serious side effects, including a slower heart rate, low blood pressure, and even heart failure. It also carries a high risk of addiction and overdose. Misusing opioids is a major concern, and using them with gabapentin can exacerbate these risks.
In summary, both gabapentin and oxycodone have been linked to misuse and serious safety concerns, especially when used together. Always consider these risks and consult a healthcare professional before joining a trial involving these drugs.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using gabapentin and oxycodone together for recreational opioid use because they target the condition differently than typical opioid treatments. While standard treatments often rely solely on opioids like methadone or buprenorphine, gabapentin works by calming nerve activity, potentially enhancing pain relief and reducing the need for higher opioid doses. By combining gabapentin with oxycodone, there’s hope for improved effectiveness with potentially fewer side effects and a reduced risk of dependency. This combination could offer a new pathway for managing recreational opioid use by addressing both pain and nerve activity simultaneously.
What evidence suggests that this trial's treatments could be effective for recreational opioid use?
This trial will evaluate the effects of gabapentin and oxycodone, both separately and in combination, on recreational opioid use. Research has shown that gabapentin treats nerve pain and seizures, benefiting about 30–40% of patients with conditions like diabetic nerve pain. However, misuse can occur, especially when combined with opioids. Oxycodone, a strong painkiller, carries a high risk of misuse and addiction due to its euphoric effects. Combining gabapentin with oxycodone might increase misuse risk, as both drugs have been linked to abuse when used together. The effectiveness of this combination for treating recreational opioid use remains under study, with concerns about its potential for abuse.678910
Are You a Good Fit for This Trial?
This trial is for healthy adults who occasionally use opioids recreationally but are not dependent on drugs. Participants must be in good health and able to safely take the study medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Qualification
Participants undergo a qualification phase requiring inpatient stay at the clinical research unit for 3 nights
Treatment
Participants undergo 6 treatment periods with each dosing day separated by a washout period of at least 4 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gabapentin
- Oxycodone
Trial Overview
The study tests how likely people are to misuse gabapentin alone, oxycodone alone, or both together compared to a placebo. Different doses of gabapentin (600mg and 1200mg) with or without oxycodone (20mg) are given by mouth under controlled conditions.
How Is the Trial Designed?
6
Treatment groups
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viatris Inc.
Lead Sponsor
Dr. Vince Clinical Research
Collaborator
Citations
Gabapentin: Uses, Side Effects, Dosages, Interactions & ...
A small number of studies have reported misuse and abuse of gabapentin. Overdoses on gabapentin have been reported. Individuals experienced ...
Gabapentin (oral route) - Side effects & dosage
Description. Gabapentin is used to help control partial seizures (convulsions) in the treatment of epilepsy. This medicine cannot cure epilepsy and will ...
Gabapentin for Off-Label Use: Evidence-Based or Cause for ...
Patients with prolonged overuse of concomitant gabapentin and opioids were significantly more likely to experience an all-cause or drug-related inpatient ...
Gabapentin: MedlinePlus Drug Information
Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain.
About gabapentin
Most people who take gabapentin do not get any side effects, but some people may feel sleepy, tired and dizzy. Common side effects are usually mild and go away ...
Gabapentin misuse, abuse, and diversion: A systematic review
Recent cross-sectional studies of opioid abuse samples in the US and UK estimated gabapentin misuse to be between 15–22% (42, 44, 45) and gabapentin abuse with ...
Risks Associated with Use of Gabapentin
There are increasing reports of gabapentin being misused and abused for recreation, self-medication, and/or self-harm. Patients with a history ...
Gabapentin Background Report
The aim of this report is to understand the increase in gabapentin prescription and overdose deaths, recognize the risks involved with co-prescriptions of ...
Gabapentin Use and Dose in Substance Use Disorders
Conclusion: High-dose gabapentin use can be predictive of opiate misuse disorder. Requests for high-dose gabapentin from patients may signal ...
Gabapentin, opioids, and the risk of opioid-related death
We found that concomitant gabapentin and opioid exposure was associated with a 49% higher risk of dying from an opioid overdose. What do these ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.