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Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056182
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
US WorldMeds LLC
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 14, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
Successful Vivitrol induction [ Time Frame: up to 10 days of detoxification and induction ]
number of participants inducted onto Vivitrol
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04056182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Official Title  ICMJE Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Brief 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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
open label treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE 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.
Other Name: Lucemyra
Study Arms  ICMJE Experimental: Lofexidine
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.
Intervention: Drug: Lofexidine 0.18 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Mahony, LMHC 6467748183 amy.mahony@nyspi.columbia.edu
Contact: Daniel J Brooks, LMSW 6467748192 daniel.brooks@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04056182
Other Study ID Numbers  ICMJE 7812
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Responsible Party Frances R Levin, New York State Psychiatric Institute
Study Sponsor  ICMJE Frances R Levin
Collaborators  ICMJE US WorldMeds LLC
Investigators  ICMJE
Principal Investigator: FRANCES R (MD) R LEVIN, MD New York Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP