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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DA033276-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Lofexidine | Other | During this open-label study, subjects will be given the option to receive lofexidine tablets for 7 days and up to 14 days if requested. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lofexidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Occurrence of Treatment Emergent Adverse Events (TEAEs) | Subjects with at least 1 TEAE occurring on days 1-14. | Days 1-14 |
| Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs) | Days 1-14 | |
| Overall Treatment Emergent Adverse Events (TEAEs) by Severity | Days 1-14 | |
| Occurrence of Per Protocol Adverse Events of Special Interest (AESI) | Day 1 to Day 14 | |
| Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles W Gorodetzky, MD, PhD | US WorldMeds | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72211 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | OL: Lofexidine HCl | Lofexidine: All enrolled subjects will take lofexidine orally, 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. Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2015 | Feb 1, 2021 |
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|
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | Day 1 to Day 14 |
| Clinical Laboratory Test Change From Baseline: Urinalysis | 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. | Day 1 and Day 14 |
| Springdale |
| Arkansas |
| 72764 |
| United States |
| San Diego | California | 92103 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Hollywood | Florida | 33021 | United States |
| Orlando | Florida | 32801 | United States |
| Atlanta | Georgia | 30331 | United States |
| Winfield | Illinois | 60190 | United States |
| Lake Charles | Louisiana | 70629 | United States |
| Rockville | Maryland | 20853 | United States |
| Flowood | Mississippi | 39232 | United States |
| St Louis | Missouri | 63141 | United States |
| New York | New York | 10019 | United States |
| Dayton | Ohio | 45417 | United States |
| Portland | Oregon | 97214 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| North Charleston | South Carolina | 29405 | United States |
| Orem | Utah | 84058 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OL: Lofexidine HCl | Lofexidine: All enrolled subjects will take lofexidine orally, 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. Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||||
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Occurrence of Treatment Emergent Adverse Events (TEAEs) | Subjects with at least 1 TEAE occurring on days 1-14. | Posted | Count of Participants | Participants | Days 1-14 |
|
|
| |||||||||||||||||||||||||||
| Primary | Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs) | Posted | Count of Participants | Participants | Days 1-14 |
|
| |||||||||||||||||||||||||||||
| Primary | Overall Treatment Emergent Adverse Events (TEAEs) by Severity | Posted | Count of Participants | Participants | Days 1-14 |
|
| |||||||||||||||||||||||||||||
| Primary | Occurrence of Per Protocol Adverse Events of Special Interest (AESI) | Posted | Count of Participants | Participants | Day 1 to Day 14 |
|
| |||||||||||||||||||||||||||||
| Primary | Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal | Posted | Count of Participants | Participants | Day 1 to Day 14 |
|
| |||||||||||||||||||||||||||||
| Primary | 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. | Participants Analyzed does not match the Participant Flow because some patient data was missing for the visit. | Posted | Mean | Standard Deviation | mmHg | Day 1 to Day 14 |
| |||||||||||||||||||||||||||
| Primary | 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. | Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit. | Posted | Mean | Standard Deviation | mmHg | Day 1 to Day 14 |
| |||||||||||||||||||||||||||
| Primary | 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. | Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit. | Posted | Mean | Standard Deviation | mmHg | Day 1 to Day 14 |
| |||||||||||||||||||||||||||
| Primary | 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. | Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit. | Posted | Mean | Standard Deviation | mmHg | Day 1 to Day 14 |
| |||||||||||||||||||||||||||
| Primary | 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. | Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Day 1 to Day 14 |
| |||||||||||||||||||||||||||
| Primary | 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. | Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Day 1 to Day 14 |
| |||||||||||||||||||||||||||
| Primary | 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. | Suicidality: The number and percentage of subjects reporting any suicidal ideation OR behavior throughout the assessment period, including baseline. | Posted | Count of Participants | Participants | Day 1 to Day 14 |
|
| |||||||||||||||||||||||||||
| Primary | Clinical Laboratory Test Change From Baseline: Hematology | Hematology Parameters with Shifts in ≥3% of Subjects from Screening to End of Study | The number of participants analyzed for each parameter differs from the overall number of participants analyzed as a result of missing data for some participants. | Posted | Count of Participants | Participants | Day 1 to Day 14 |
| ||||||||||||||||||||||||||||
| Primary | Clinical Laboratory Test Change From Baseline: Chemistry | Chemistry Parameters with Shifts in ≥3% of Subjects from Screening to End of Study | Participants Analyzed does not match the Participant Flow as a result of missing data for some participants. | Posted | Count of Participants | Participants | Day 1 to Day 14 |
| ||||||||||||||||||||||||||||
| Primary | Clinical Laboratory Test Change From Baseline: Urinalysis | Participants Analyzed does not match the Participant Flow as a result of missing data for some participants. | Posted | Count of Participants | Participants | Day 1 to Day 7 |
| |||||||||||||||||||||||||||||
| Primary | 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. | Participants Analyzed does not match the Participant Flow as a result of missing data for some participants. | Posted | Count of Participants | Participants | Day 1 and Day 14 |
|
|
AEs will be followed starting with dosing on Day 1 through Day 14, and will be evaluated as well on a 30-day post-last dose follow-up phone call.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OL: Lofexidine HCl | Lofexidine: All enrolled subjects will take lofexidine orally, 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. Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested. | 0 | 286 | 2 | 286 | 270 | 286 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delusion | Psychiatric disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sedation | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
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| Restlessness | Psychiatric disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | USWM, LLC | 1-888-900-8796 | medinfo@usworldmeds.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2016 | Feb 1, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2015 | Feb 3, 2021 | ICF_002.pdf |
| ID | Term |
|---|---|
| C025655 | lofexidine |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories |
|---|
| Mild |
| |||||
| Moderate |
| |||||
| Severe |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Orthostatic hypotension |
| |||||
| Orthostatic bradycardia |
| |||||
| Syncope |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Opioid Withdrawal Related Adverse Events |
| |||||
| Non-Opioid Withdrawal Related Adverse Events |
|
| OG002 | Inpatient: Pre 1PM | Lofexidine: 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. |
| OG003 | Inpatient: 3.5 hr Post 1PM | Lofexidine: 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. |
| OG004 | Inpatient: Pre 6PM | Lofexidine: 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. |
| OG005 | Inpatient: 3.5 hr Post 6PM | Lofexidine: 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. |
| OG006 | Inpatient: Pre 11PM | Lofexidine: 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. |
| OG007 | Outpatient: Predose | Lofexidine: 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. |
| OG008 | Outpatient: 3.5 hr Postdose | Lofexidine: 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. |
|
|
| OG002 | Inpatient: Pre 1PM | Lofexidine: 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. |
| OG003 | Inpatient: 3.5 hr Post 1PM | Lofexidine: 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. |
| OG004 | Inpatient: Pre 6PM | Lofexidine: 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. |
| OG005 | Inpatient: 3.5 hr Post 6PM | Lofexidine: 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. |
| OG006 | Inpatient: Pre 11PM | Lofexidine: 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. |
| OG007 | Outpatient: Predose | Lofexidine: 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. |
| OG008 | Outpatient: 3.5 hr Postdose | Lofexidine: 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. |
|
|
| OG002 | Inpatient: Pre 1PM | Lofexidine: 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. |
| OG003 | Inpatient: 3.5 hr Post 1PM | Lofexidine: 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. |
| OG004 | Inpatient: Pre 6PM | Lofexidine: 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. |
| OG005 | Inpatient: 3.5 hr Post 6PM | Lofexidine: 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. |
| OG006 | Inpatient: Pre 11PM | Lofexidine: 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. |
| OG007 | Outpatient: Predose | Lofexidine: 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. |
| OG008 | Outpatient: 3.5 hr Postdose | Lofexidine: 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. |
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| OG002 | Inpatient: Pre 1PM | Lofexidine: 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. |
| OG003 | Inpatient: 3.5 hr Post 1PM | Lofexidine: 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. |
| OG004 | Inpatient: Pre 6PM | Lofexidine: 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. |
| OG005 | Inpatient: 3.5 hr Post 6PM | Lofexidine: 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. |
| OG006 | Inpatient: Pre 11PM | Lofexidine: 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. |
| OG007 | Outpatient: Predose | Lofexidine: 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. |
| OG008 | Outpatient: 3.5 hr Postdose | Lofexidine: 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. |
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| OG002 | Inpatient: Pre 1PM | Lofexidine: 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. |
| OG003 | Inpatient: 3.5 hr Post 1PM | Lofexidine: 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. |
| OG004 | Inpatient: Pre 6PM | Lofexidine: 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. |
| OG005 | Inpatient: 3.5 hr Post 6PM | Lofexidine: 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. |
| OG006 | Inpatient: Pre 11PM | Lofexidine: 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. |
| OG007 | Outpatient: Predose | Lofexidine: 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. |
| OG008 | Outpatient: 3.5 hr Postdose | Lofexidine: 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. |
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| OG002 | Inpatient: Pre 1PM | Lofexidine: 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. |
| OG003 | Inpatient: 3.5 hr Post 1PM | Lofexidine: 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. |
| OG004 | Inpatient: Pre 6PM | Lofexidine: 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. |
| OG005 | Inpatient: 3.5 hr Post 6PM | Lofexidine: 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. |
| OG006 | Inpatient: Pre 11PM | Lofexidine: 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. |
| OG007 | Outpatient: Predose | Lofexidine: 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. |
| OG008 | Outpatient: 3.5 hr Postdose | Lofexidine: 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. |
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| OG002 | Above Baseline (End of Study) | Shifts from normal at baseline to above baseline at the last post-baseline assessment for hematology parameters occurring in ≥3% of subjects. Lofexidine: All enrolled subjects will take lofexidine orally, 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. |
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| OG002 |
| Above Baseline (End of Study) |
Shifts from normal at baseline to above baseline at the last post-baseline assessment for hematology parameters occurring in ≥3% of subjects. Lofexidine: All enrolled subjects will take lofexidine orally, 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. |
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Shifts from normal at baseline to above baseline at the last post-baseline assessment for hematology parameters occurring in ≥3% of subjects. Lofexidine: All enrolled subjects will take lofexidine orally, 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. |
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| Abnormal (NCS) |
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| Abnormal (CS) |
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| Title | Measurements |
|---|---|
| Normal |
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| Abnormal (NCS) |
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| Abnormal (CS) |
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| Title | Measurements |
|---|---|
| Normal |
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| Abnormal (NCS) |
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| Abnormal (CS) |
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