Opioid Withdrawal Management for Opioid Use Disorder
Trial Summary
What is the purpose of this trial?
Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on methadone or buprenorphine maintenance treatment, you cannot participate in the trial.
What data supports the idea that Opioid Withdrawal Management for Opioid Use Disorder is an effective drug?
The available research shows that lofexidine, when used in combination with naloxone, helps reduce withdrawal symptoms and cravings during detoxification. In a study comparing lofexidine/naloxone to lofexidine/placebo, patients who received naloxone experienced lower levels of withdrawal by the end of detoxification. Another study compared lofexidine with other drugs like buprenorphine/naloxone and methadone, showing that lofexidine can be effective in managing withdrawal symptoms. However, the research also indicates that lofexidine does not significantly speed up the withdrawal process compared to other treatments.12345
What safety data is available for opioid withdrawal treatments like Lofexidine?
Safety data for Lofexidine, a non-opioid treatment for opioid withdrawal, is available from several studies. A randomized controlled clinical trial investigated its safety and efficacy for treating opioid withdrawal syndrome. Another study reviewed its pharmacology, efficacy, and safety following FDA approval. Additionally, research examined its effects on cardiac repolarization during treatment. Lofexidine has been evaluated in combination with oral naltrexone for opioid use disorder relapse prevention, focusing on safety and treatment compliance.14678
Is the drug Lofexidine, also known as Lucemyra, a promising treatment for opioid withdrawal?
Research Team
Kelly E Dunn, Ph.D, M.B.A.
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for adults aged 18-65 with opioid use disorder who are physically dependent on opioids and interested in tapering off. It's not for those dependent on alcohol or benzodiazepines, pregnant or breastfeeding women, people on methadone/buprenorphine treatment, or those with significant heart issues, mental health disorders, active hepatitis B/C infections with abnormal liver tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Morphine Stabilization
Participants are maintained on morphine for stabilization and undergo naloxone challenges to assess withdrawal symptoms
Lofexidine-assisted Taper
Participants are tapered off morphine using lofexidine to manage withdrawal symptoms
Transition to Aftercare
Participants transition to buprenorphine maintenance or receive oral naltrexone and an injection of Vivitrol
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lofexidine
- Morphine
- Naloxone
- Naloxone + Lofexidine
Lofexidine is already approved in United States, United Kingdom for the following indications:
- Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
- Management of opioid withdrawal symptoms
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Johns Hopkins University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator