Clinical Trials Logo

Clinical Trial Summary

This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids.


Clinical Trial Description

This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. Lofexidine is a nonopioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when a person stops taking an opioid suddenly. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids. Lofexidine will be fixed-flexible dosing started on day 1 with maximum dose being three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals. Lofexidine treatment will continue throughout the detoxification, up to 10 days, and will be discontinued with a gradual dose reduction over 2 to 4 days. Precipitated withdrawal symptoms are treated with lofexidine, clonazepam, and other comfort medications. After the induction patients will be seen at the clinic for 8 weeks. Twice weekly for the first month and weekly for weeks 5-8. A second Vivitrol injection will be provided at week 4. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04056182
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 2
Start date September 1, 2019
Completion date January 29, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Active, not recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed NCT04464421 - SMART Effectiveness Trial N/A
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A
Completed NCT03766893 - Medication Maintenance Therapy in Community Pharmacy Settings Early Phase 1