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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04056182 |
Recruitment Status :
Completed
First Posted : August 14, 2019
Results First Posted : December 9, 2021
Last Update Posted : December 9, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opioid-use Disorder | Drug: Lofexidine 0.18 MG | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | open label treatment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment |
Actual Study Start Date : | September 1, 2019 |
Actual Primary Completion Date : | January 29, 2021 |
Actual Study Completion Date : | January 29, 2021 |
Arm | Intervention/treatment |
---|---|
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.
|
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 |
- Successful Vivitrol Induction [ Time Frame: up to 10 days of detoxification and induction ]number of participants inducted onto Vivitrol
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056182
United States, New York | |
STARS/NYSPI-Columbia University | |
New York, New York, United States, 10019 |
Principal Investigator: | FRANCES R (MD) R LEVIN, MD | New York Psychiatric Institute |
Documents provided by Frances R Levin, New York State Psychiatric Institute:
Responsible Party: | Frances R Levin, Research Psychiatrist, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT04056182 |
Other Study ID Numbers: |
7812 |
First Posted: | August 14, 2019 Key Record Dates |
Results First Posted: | December 9, 2021 |
Last Update Posted: | December 9, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is not a plan to make IPD available. |
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 |
opioid use disorder lofexidine naltrexon-xr |
Lofexidine Opioid-Related Disorders Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Antihypertensive Agents Narcotic Antagonists Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |