The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and buprenorphine. This study will take place in a variety of clinical scenarios, both in-clinic and outpatient settings.
Eligible subjects (person seeking treatment for partial or total opioid withdrawal) enrolled in this study are required to take lofexidine for a minimum of 7 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
286
All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Springdale, Arkansas, United States
Unnamed facility
San Diego, California, United States
Overall Occurrence of Treatment Emergent Adverse Events (TEAEs)
Subjects with at least 1 TEAE occurring on days 1-14.
Time frame: Days 1-14
Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs)
Time frame: Days 1-14
Overall Treatment Emergent Adverse Events (TEAEs) by Severity
Time frame: Days 1-14
Occurrence of Per Protocol Adverse Events of Special Interest (AESI)
Time frame: Day 1 to Day 14
Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal
Time frame: Day 1 to Day 14
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
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Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Hollywood, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Winfield, Illinois, United States
Unnamed facility
Lake Charles, Louisiana, United States
Unnamed facility
Rockville, Maryland, United States
...and 8 more locations
Time frame: Day 1 to Day 14
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column "Inpatient: Pre 8AM"; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
The C-SSRS measures both suicidal ideation and suicidal behavior and will be completed to assess lifetime suicidality before first dose of study drug, 3.5 hours after first daily dose of study drug on in-clinic treatment days, and then once a day before dosing during outpatient treatment days. C-SSRS will also be assessed at end of study/discontinuation.
Time frame: Day 1 to Day 14
Clinical Laboratory Test Change From Baseline: Hematology
Hematology Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Time frame: Day 1 to Day 14
Clinical Laboratory Test Change From Baseline: Chemistry
Chemistry Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Time frame: Day 1 to Day 14
Clinical Laboratory Test Change From Baseline: Urinalysis
Time frame: Day 1 to Day 7
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
For each 12-lead ECG obtained during the study, the investigator made an overall interpretation of the ECG (normal, abnormal NCS, and abnormal CS). Shifts from normal at baseline to abnormal NCS and abnormal CS at the end of study predose and postdose assessments were summarized.
Time frame: Day 1 and Day 14