Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction

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: NCT02801357
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date October 26, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
Predose and peak metabolite (N-[2- aminoethyl-2-[2,6-dichlorophenoxy] propanamide [LADP], 2-[2,6-dichlorophenoxy] propionic acid [LDPA] and 2,6-Dichlorophenol [2,6-DCP]) plasma concentration to lofexidine (parent) ratios on each day of treatment [ Time Frame: pre-1 PM dose and 3 hours post-1 PM dose on Days 1-6; pre-8 AM dose and 1, 3, 7, 12, 24, and 34 hours post-8 AM dose on Day 7 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
  • Modified Clinical Global Impression - subject and observer [ Time Frame: 3.5 hours post-8 AM dose on Days 1-7 ]
  • Visual Analog Scale for Efficacy [ Time Frame: 3.5 hours post-8 AM dose on Days 1-7 ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline: Day -1; 3.5 hours post-first dose on Day 1; Day 8 ]
  • Holter ECGs [ Time Frame: Day -1; pre-1 PM dose, 3 and 4 hours post-1 PM dose on Days 1 and 6 ]
  • Blood pressure and pulse (sitting and standing) [ Time Frame: screening; Day -1; within 30 minutes before every dose Days 1-8 ]
  • Laboratory Assessments [ Time Frame: screening ]
    Measurements in hematology, chemistry, urinalysis, infectious disease panel. Labs will be done at screening.
  • Oral temperature and respiration [ Time Frame: screening; Day -1; pre-8 AM dose on Days 1-8 ]
  • 12-Lead ECG [ Time Frame: screening ]
  • Adverse Events Assessment [ Time Frame: Day -1; Days 1-8 ]
  • Urine drug screening [ Time Frame: Screening; Day -1, Days 1-8 ]
  • Concomitant medications [ Time Frame: Screening; Day -1, Days 1-8 ]
  • Physical exam [ Time Frame: screening; Day -1; Day 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
Official Title  ICMJE A Phase 1 Study to Evaluate the Relative Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
Brief Summary The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
Detailed Description This is a Phase 1, open-label, inpatient study in male and female subjects seeking at least a 4 mg reduction of their buprenorphine maintenance dose. The purpose of this study is to assess the relative exposures of lofexidine and its 3 major metabolites in subjects tapering from buprenorphine maintenance treatment. Lofexidine is an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Withdrawal Syndrome
  • Opiate Addiction
  • Opiate Dependence
Intervention  ICMJE Drug: lofexidine administration in subjects seeking buprenorphine dose reduction
Study Arms  ICMJE Experimental: lofexidine with tapering buprenorphine
Enrolled subjects must be on a daily dose of between 8 - 24 mg of buprenorphine for at least 30 days. Once enrolled, subjects will receive lofexidine as follows: Days 1 through 3, 0.6 mg 4 times daily (QID; 2.4 mg daily); Days 4 through 6, 0.8 mg QID (3.2 mg daily), and Day 7 0.8 mg at 8 AM. Subjects will take their scheduled lofexidine doses at approximately 8 AM, 1 PM, 6 PM and 11 PM. Subjects will also reduce their current buprenorphine dose by at least 4 mg on Day 1.
Intervention: Drug: lofexidine administration in subjects seeking buprenorphine dose reduction
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have current dependency such that the subject is maintained on a daily dose between 8 and 24 mg of buprenorphine and is seeking reduction of their buprenorphine dose by at least 4 mg.
  • Urine toxicology screen positive for buprenorphine at Screening.
  • Agree to collection of blood samples for genotyping of CYP2D6 metabolizer status.
  • If female and of childbearing potential, subject must have been using birth control for at least 30 days and must agree to use an acceptable form of birth control through at least 30 days after the last dose of study drug.
  • If male, must agree to use an acceptable form of birth control throughout the entire study period and for 90 days after the last dose of study drug. Must not donate sperm for 90 days after the last dose of study drug.

Exclusion Criteria:

  • Be a female subject who is pregnant or lactating.
  • Have a very serious medical illness not under control.
  • Have participated in an investigational drug study within the past 30 days.
  • Received any drugs that are known strong, moderate or weak inhibitors of cytochrome P450 (CYP) enzymes CYP1A2, CYP2C19, or CYP2D6, within 14 days or 5 half-lives (whichever is more) before Day -1.
  • Abnormal cardiovascular exam at Screening.
  • Subjects requiring the following will be excluded: Tricyclic antidepressants, which may reduce the efficacy of imidazoline derivatives; Beta-receptor blockers, to avoid the risk of excessive bradycardia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02801357
Other Study ID Numbers  ICMJE USWM- LX1-1013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party US WorldMeds LLC
Study Sponsor  ICMJE US WorldMeds LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account US WorldMeds LLC
Verification Date October 2017

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