Opioid-use Disorder Clinical Trial
Official title:
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
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.
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. ;
| 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 |
NCT05028998 -
COVID-19-Related Opioid Treatment Policy Evaluation
|
||
| Recruiting |
NCT04927143 -
Encouraging Abstinence Behavior in a Drug Epidemic
|
Phase 2 | |
| 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
|
||
| Suspended |
NCT02687360 -
Imaging the Effects of rTMS on Chronic Pain
|
N/A | |
| Completed |
NCT03766893 -
Medication Maintenance Therapy in Community Pharmacy Settings
|
Early Phase 1 | |
| Completed |
NCT03279562 -
Patient Driven Recovery With Nalmefene and Coaching
|
Phase 1 |