Opioid WithdrawalPhase 3NU LEAFNCT02363998
Open-Label, Safety Study of Lofexidine
A Phase 3 study testing Lofexidine in people with Opioid Withdrawal, run by USWM, LLC (dba US WorldMeds) at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Withdrawal
- What is being tested?
- Lofexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2015to Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female at least 18 years of age
- Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Must have current dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.), on any opioid (including methadone and buprenorphine maintenance treatment)
- Must be seeking treatment for partial or total withdrawal from current opioid and expected, as determined by the Principal Investigator, to benefit from lofexidine treatment for at least 7 days at clinically relevant doses. This can include a variety of clinical situations where opioid withdrawal illness is likely to occur including abrupt and total withdrawal (including from methadone and buprenorphine), agonist-assisted total withdrawal, dose reduction of maintenance treatment (e.g., methadone, buprenorphine) and transition from an opioid agonist to naltrexone or buprenorphine maintenance
- Must have Urine toxicology screen result of positive for opioid(s) relevant to the subject's withdrawal treatment goal
- If female and of childbearing potential, subject must agree to use of one of the following methods of birth control including oral contraceptives, patch, barrier (diaphragm, sponge or condom) plus spermicidal preparations, intrauterine contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring or surgical sterilization or partner sterile (with documented proof)
Who cannot join
- Female subject who is pregnant or lactating
- History of very serious medical illness not under control including, but not limited to, active self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks and/or having an unstable psychiatric condition. These conditions will be determined at Screening by medical history, physical examination, 12 lead electrocardiogram (duplicate), clinical laboratory tests for infectious diseases, and a tuberculin test
- Current dependence (based on the M.I.N.I.) on any psychoactive substance (excluding caffeine, nicotine, and the subject's current opioid-dependence agent, which can include methadone and buprenorphine, for example, in agonist-maintained subjects) that requires detoxification or dose reduction as part of the pre-defined individual subject withdrawal treatment goal
- Have participated in an investigational drug study within the past 30 days
- Have a history of lofexidine exposure in a prior clinical trial or otherwise
- Have an abnormal cardiovascular exam at screening
- Any subject that requires tricyclic antidepressants, which may reduce the efficacy of imidazoline derivatives and/or beta-receptor blockers, to avoid the risk of excessive bradycardia
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Atlanta, Georgia, 30331
Study site
Dayton, Ohio, 45417
Study site
Flowood, Mississippi, 39232
Study site
Fort Lauderdale, Florida, 33308
Study site
Hollywood, Florida, 33021
Study site
Lake Charles, Louisiana, 70629
Study site
Little Rock, Arkansas, 72211
Study site
New York, New York, 10019
Study site
North Charleston, South Carolina, 29405
Study site
Orem, Utah, 84058
Study site
Orlando, Florida, 32801
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Oregon, 97214
Study site
Rockville, Maryland, 20853
Study site
San Diego, California, 92103
Study site
Springdale, Arkansas, 72764
Study site
St Louis, Missouri, 63141
Study site
Winfield, Illinois, 60190
About this study
Official title: A Phase 3, Open-Label, Safety Study of Lofexidine
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.
Read the detailed description
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.
- Conditions
- Opioid Withdrawal
- Being tested
- Lofexidine
- Keywords
- detoxification, agonist taper, methadone step down, buprenorphine step down, opioid withdrawal syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LofexidineDrug
Also called Lofexidine hydrochloride (HCL)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lofexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Occurrence of Treatment Emergent Adverse Events (TEAEs)
Subjects with at least 1 TEAE occurring on days 1-14.
Measured: Days 1-14
Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs)
Measured: Days 1-14
Overall Treatment Emergent Adverse Events (TEAEs) by Severity
Measured: Days 1-14
Occurrence of Per Protocol Adverse Events of Special Interest (AESI)
Measured: Day 1 to Day 14
Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 1 to Day 14
Clinical Laboratory Test Change From Baseline: Urinalysis
Measured: 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.
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- USWM, LLC (dba US WorldMeds)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Charles W Gorodetzky, MD, PhD, Study director, US WorldMeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363998
- Sponsor's protocol ID
- USWM-LX1-3003-2
- Other IDs
- 1U01DA033276-01A1
- Acronym
- NU LEAF
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2015
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Safety Study of Lofexidine
- ClinicalTrials.gov ID
- NCT02363998
- Acronym / sponsor ID
- NU LEAF / USWM-LX1-3003-2
- Conditions
- Opioid Withdrawal
- Keywords
- detoxification, agonist taper, methadone step down, buprenorphine step down, opioid withdrawal syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- USWM, LLC (dba US WorldMeds)Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Lofexidine | Other | Drug: LofexidineDuring this open-label study, subjects will be given the option to receive lofexidine tablets for 7 days and up to 14 days if requested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female at least 18 years of age
- Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Must have current dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.), on any opioid (including methadone and buprenorphine maintenance treatment)
- Must be seeking treatment for partial or total withdrawal from current opioid and expected, as determined by the Principal Investigator, to benefit from lofexidine treatment for at least 7 days at clinically relevant doses. This can include a variety of clinical situations where opioid withdrawal illness is likely to occur including abrupt and total withdrawal (including from methadone and buprenorphine), agonist-assisted total withdrawal, dose reduction of maintenance treatment (e.g., methadone, buprenorphine) and transition from an opioid agonist to naltrexone or buprenorphine maintenance
- Must have Urine toxicology screen result of positive for opioid(s) relevant to the subject's withdrawal treatment goal
Key exclusion criteria (7 listed)
- Female subject who is pregnant or lactating
- History of very serious medical illness not under control including, but not limited to, active self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks and/or having an unstable psychiatric condition. These conditions will be determined at Screening by medical history, physical examination, 12 lead electrocardiogram (duplicate), clinical laboratory tests for infectious diseases, and a tuberculin test
- Current dependence (based on the M.I.N.I.) on any psychoactive substance (excluding caffeine, nicotine, and the subject's current opioid-dependence agent, which can include methadone and buprenorphine, for example, in agonist-maintained subjects) that requires detoxification or dose reduction as part of the pre-defined individual subject withdrawal treatment goal
- Have participated in an investigational drug study within the past 30 days
- Have a history of lofexidine exposure in a prior clinical trial or otherwise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LofexidineAlso: Lofexidine hydrochloride (HCL)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. | Drug | Open Label Lofexidine |
Primary outcome
Overall Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Days 1-14
Subjects with at least 1 TEAE occurring on 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
Time frame: Day 1 to Day 14
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.
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Time frame: Day 1 to Day 14
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.
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Time frame: Day 1 to Day 14
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.
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Time frame: Day 1 to Day 14
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.
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Time frame: Day 1 to Day 14
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.
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Time frame: Day 1 to Day 14
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.
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
Time frame: Day 1 to Day 14
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.
Clinical Laboratory Test Change From Baseline: Hematology
Time frame: Day 1 to Day 14
Hematology Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Clinical Laboratory Test Change From Baseline: Chemistry
Time frame: Day 1 to Day 14
Chemistry Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
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
Time frame: Day 1 and Day 14
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles W Gorodetzky, MD, PhD study director
US WorldMeds
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lofexidine in people with Opioid Withdrawal, run by USWM, LLC (dba US WorldMeds) at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: Days 1-14). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.