60 Participants Needed

Opioid Withdrawal Management for Opioid Use Disorder

KE
CG
BL
KE
Overseen ByKelly E Dunn, PhD, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Yes, Lofexidine is a promising drug for managing opioid withdrawal. It is a non-opioid medication that helps reduce withdrawal symptoms by calming the body's response to stopping opioids. It has been approved in several countries and has shown effectiveness and safety in clinical trials.12369

Research Team

KE

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

Opioid-positive urine sample

Exclusion Criteria

Clinically significant hypotension (<90/60mmHg) or bradycardia (<45bpm)
I have hepatitis B or C, but my liver is functioning normally.
Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Morphine Stabilization

Participants are maintained on morphine for stabilization and undergo naloxone challenges to assess withdrawal symptoms

5 days
Daily monitoring

Lofexidine-assisted Taper

Participants are tapered off morphine using lofexidine to manage withdrawal symptoms

5 days
Daily monitoring

Transition to Aftercare

Participants transition to buprenorphine maintenance or receive oral naltrexone and an injection of Vivitrol

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lofexidine
  • Morphine
  • Naloxone
  • Naloxone + Lofexidine
Trial Overview The study is testing how different treatments affect opioid withdrawal symptoms during a medication taper. Treatments include Naloxone combined with a placebo or lofexidine (a non-opioid medication), and Morphine as comparisons to understand individual responses to withdrawal.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Within-subject designExperimental Treatment4 Interventions
All participants will undergo the same study design, which includes morphine stabilization (days 1-5), two naloxone challenges (scheduled during morphine stabilization), lofexidine-assisted taper (days 6-10), and transition to aftercare (day 11).

Lofexidine is already approved in United States, United Kingdom for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Lucemyra for:
  • Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
πŸ‡¬πŸ‡§
Approved in United Kingdom as BritLofex for:
  • Management of opioid withdrawal symptoms

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

Lofexidine hydrochloride (Lucemyra) is effective in managing opioid withdrawal symptoms, providing a non-opioid treatment option for individuals undergoing detoxification.
Erenumab-aooe (Aimovig) has been shown to significantly reduce the frequency of migraine attacks, offering a targeted approach to migraine prevention.
Pharmaceutical Approval Update.Choy, M.[2020]
Lofexidine is an effective option for managing symptoms of opiate withdrawal by reducing sympathetic outflow, but it remains largely experimental in the US and Canada despite its approval in other regions since the 1980s.
The development of lofexidine has faced challenges due to market factors and regulatory considerations, but recent clinical trials are starting to rectify past oversights by exploring improved formulations and specific enantiomers.
The preclinical discovery of lofexidine for the treatment of opiate addiction.Vartak, AP.[2014]
In a randomized controlled trial involving 80 opiate-dependent individuals, both buprenorphine/naloxone and methadone/lofexidine showed similar overall outcomes in managing opiate withdrawal symptoms and treatment retention.
However, during the induction phase, withdrawal symptoms decreased more slowly and cravings were higher in the buprenorphine/naloxone group, while methadone/lofexidine led to earlier peak withdrawal symptoms during detoxification.
Buprenorphine/naloxone versus methadone and lofexidine in community stabilisation and detoxification: A randomised controlled trial of low dose short-term opiate-dependent individuals.Law, FD., Diaper, AM., Melichar, JK., et al.[2018]

References

Pharmaceutical Approval Update. [2020]
The preclinical discovery of lofexidine for the treatment of opiate addiction. [2014]
Buprenorphine/naloxone versus methadone and lofexidine in community stabilisation and detoxification: A randomised controlled trial of low dose short-term opiate-dependent individuals. [2018]
Lofexidine in Combination With Oral Naltrexone for Opioid Use Disorder Relapse Prevention: A Pilot Randomized, Double-Blind, Placebo-Controlled Study. [2020]
The effectiveness of combined naloxone/lofexidine in opiate detoxification: results from a double-blind randomized and placebo-controlled trial. [2016]
Effect of lofexidine on cardiac repolarization during treatment of opioid withdrawal. [2020]
Safety and Efficacy of Lofexidine for Medically Managed Opioid Withdrawal: A Randomized Controlled Clinical Trial. [2020]
Lofexidine: A Newly FDA-Approved, Nonopioid Treatment for Opioid Withdrawal. [2020]
Lofexidine for acute opioid withdrawal: A clinical case series. [2022]