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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04056182
Other study ID # 7812
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2019
Est. completion date January 29, 2021

Study information

Verified date December 2021
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 29, 2021
Est. primary completion date January 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals between the ages of 18-60 - Meets DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids on day of consent - Seeking treatment for opioid use disorder - Capable of giving informed consent and complying with study procedures - History of opioid withdrawal Exclusion Criteria: - Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis - Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk - Methadone maintenance or long-acting agonist (buprenorphine) treatment -Buprenorphine maintenance treatment - Known history of allergy, intolerance, or hypersensitivity to candidate medication - Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients - Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure >150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT >3 times the upper limit of normal) - Legally mandated to substance use disorder treatment - Currently physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary - Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications (Clinical interview; psychiatrist)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lofexidine 0.18 MG
Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.

Locations

Country Name City State
United States STARS/NYSPI-Columbia University New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute US WorldMeds LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful Vivitrol Induction number of participants inducted onto Vivitrol up to 10 days of detoxification and induction
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