Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Intervention: Lofexidine 0.18 MG
Intervention description: 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 MeSH terms: Lofexidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label treatment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: opioid use disorder; lofexidine; naltrexon-xr

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.
    

Eligibility criteria:

        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)