Number of Treatment Emergent AEs and SAEs
Primary
· Day 1 through Day 28
Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 0 | |
| Placebo | 5 |
Serious Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 0 | |
| Placebo | 0 |
Last reviewed · How we verify
NCT04070157: TAPER
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Terminated
Phase 2
Results posted
Last updated 21 October 2024
What this trial tests
Phase 2 trial testing Lofexidine in Opioid Withdrawal (Disorder) in 4 participants. Terminated before completion.
Timeline
2 August 2019
Primary endpoint
27 November 2019
27 November 2019
27 November 2019
Quick facts
| Lead sponsor | USWM, LLC (dba US WorldMeds) |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 2 August 2019 |
| Primary completion | 27 November 2019 |
| Estimated completion | 27 November 2019 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Lofexidine (LOFEXIDINE) — full drug profile →
- Placebo
Conditions studied
- Opioid Withdrawal (Disorder) — all drugs for Opioid Withdrawal (Disorder) →
Sponsor
USWM, LLC (dba US WorldMeds) — full company profile →
Who can join
18 and older, any sex, with Opioid Withdrawal (Disorder). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation
Primary
· Day 1 through Day 28
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 0 | |
| Placebo | 1 |
Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests
Primary
· Day 1 through Day 28
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 0 | |
| Placebo | 0 |
Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale
Primary
· Day 1 through Day 28
The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a "yes" in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds "yes" to any of the suicidal ideation questions 1 to 3, the Investigator should ap
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 0 | |
| Placebo | 0 |
Change in Blood Pressure
Primary
· Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.
Day 1: Diastolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -2 | ± NA |
| Lofexidine: Standing | 0 | ± NA |
| Placebo: Sitting | -0.3 | ± 3.06 |
| Placebo: Standing | -0.7 | ± 3.21 |
Day 1: Systolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -6 | ± NA |
| Lofexidine: Standing | 0 | ± NA |
| Placebo: Sitting | 1.7 | ± 2.31 |
| Placebo: Standing | -0.3 | ± 1.53 |
Day 2: Diastolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -7 | ± NA |
| Placebo: Sitting | 3 | ± 5.66 |
Day 2: Systolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -25 | ± NA |
| Placebo: Sitting | 7 | ± 9.9 |
Day 3: Diastolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -16 | ± NA |
| Lofexidine: Standing | -9 | ± NA |
| Placebo: Sitting | 1.5 | ± 3.87 |
| Placebo: Standing | 5 | ± 6 |
Day 3: Systolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -52 | ± NA |
| Lofexidine: Standing | -44 | ± NA |
| Placebo: Sitting | 6.5 | ± 7.72 |
| Placebo: Standing | 6 | ± 7.94 |
Day 7: Diastolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -16 | ± NA |
| Placebo: Sitting | 7 | ± 8.72 |
Day 7: Systolic BP
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -50 | ± NA |
| Placebo: Sitting | 6 | ± 7 |
Change in Pulse
Primary
· Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Day 1
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | 1 | ± NA |
| Lofexidine: Standing | 0 | ± NA |
| Placebo: Sitting | -5 | ± 2.65 |
| Placebo: Standing | -0.3 | ± 3.21 |
Day 2
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -2 | ± NA |
| Placebo: Sitting | -9 | ± 4.24 |
Day 3
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -4 | ± NA |
| Lofexidine: Standing | -5 | ± NA |
| Placebo: Sitting | -7.3 | ± 2.63 |
| Placebo: Standing | -5.3 | ± 0.58 |
Day 7
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | 0 | ± NA |
| Placebo: Sitting | -2 | ± 9.54 |
Day 8
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -2 | ± NA |
| Lofexidine: Standing | -4 | ± NA |
| Placebo: Sitting | -1 | ± 3.46 |
| Placebo: Standing | -0.7 | ± 0.58 |
Day 14
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -1 | ± NA |
| Placebo: Sitting | -1.7 | ± 7.09 |
Day 15
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine: Sitting | -2 | ± NA |
| Lofexidine: Standing | 0 | ± NA |
| Placebo: Sitting | -11 | ± 8.19 |
| Placebo: Standing | -3 | ± 3.46 |
Day 18
| Group | Value | 95% CI |
|---|---|---|
| Placebo: Sitting | 1.7 | ± 2.89 |
Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation
Secondary
· Day 1 through Day 28
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 0 | |
| Placebo | 2 |
Change in Clinical Opiate Withdrawal Scale (COWS)
Secondary
· Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28
The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48.
Day 3
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 2 | |
| Placebo | -0.7 | ± 0.58 |
Day 8
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 3 | |
| Placebo | -1 | ± 2 |
Day 15
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 4 | |
| Placebo | -1.3 | ± 0.58 |
Day 22
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -1 | |
| Placebo | -2.5 | ± 0.71 |
End of Study
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -1 | |
| Placebo | -2.3 | ± 0.58 |
Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)
Secondary
· Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome.
Day 2
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 1 | ± NA |
| Placebo | -0.5 | ± 3 |
Day 3
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 1 | ± NA |
| Placebo | -2.2 | ± 3.56 |
Day 4
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.7 | ± 5.03 |
Day 5
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 1 | ± NA |
| Placebo | -0.3 | ± 5.51 |
Day 6
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.3 | ± 5.03 |
Day 7
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 1 | ± NA |
| Placebo | -2.5 | ± 3.54 |
Day 8
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | 1.5 | ± NA |
| Placebo | -1.4 | ± 4.72 |
Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)
Secondary
· Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome.
Day 2
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -4 | ± NA |
| Placebo | 0.3 | ± 3.77 |
Day 3
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -5 | ± NA |
| Placebo | -1 | ± 4.3 |
Day 4
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2.3 | ± 5.51 |
Day 5
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -3 | ± NA |
| Placebo | 3 | ± 6.24 |
Day 6
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 3.3 | ± 8.02 |
Day 7
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -4 | ± NA |
| Placebo | 0 | ± 5.66 |
Day 8
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine | -2.5 | ± NA |
| Placebo | 1.8 | ± 6.3 |
Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score
Secondary
· Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)
MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug. SEVERITY OF ILLNESS: 1. = No at all ill 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects SIDE EFFECTS INDEX: 1. = None, study drug is producing no side effects 2. = Do not significantly interfere with subject's functioning 3. = Significantly interferes with subject's functioning
Visit 2
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Illness Scale Averages: | 1 | ± NA |
| Placebo Severity of Illness Scale Averages: | 1 | ± NA |
| Lofexidine Side Effects Index Averages: | 1 | ± NA |
| Placebo Side Effects Index Averages: | 1 | ± NA |
Visit 3
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Illness Scale Averages: | 1 | ± NA |
| Placebo Severity of Illness Scale Averages: | 1.33 | ± 0.471 |
| Lofexidine Side Effects Index Averages: | 1 | ± NA |
| Placebo Side Effects Index Averages: | 1.33 | ± 0.471 |
Visit 4
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Illness Scale Averages: | 1 | ± NA |
| Placebo Severity of Illness Scale Averages: | 1 | ± NA |
| Lofexidine Side Effects Index Averages: | 1 | ± NA |
| Placebo Side Effects Index Averages: | 1 | ± NA |
Visit 5
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Illness Scale Averages: | 1 | ± NA |
| Placebo Severity of Illness Scale Averages: | 1 | ± NA |
| Lofexidine Side Effects Index Averages: | 1 | ± NA |
| Placebo Side Effects Index Averages: | 1 | ± NA |
EOS
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Illness Scale Averages: | 1 | ± NA |
| Placebo Severity of Illness Scale Averages: | 1 | ± NA |
| Lofexidine Side Effects Index Averages: | 1 | ± NA |
| Placebo Side Effects Index Averages: | 1 | ± NA |
Modified Clinical Global Impression - Subject Version (MCGI-S)
Secondary
· Each scheduled evaluation (Day 1 through Day 28)
Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug. SEVERITY OF OPIATE WITHDRAWAL: 1. = No opiate withdrawal symptoms 2. = On the border between no to mild opiate withdrawal symptoms 3. = Mild opiate withdrawal symptoms 4. = Moderate opiate withdrawal symptoms 5. = Marked opiate withdrawal symptoms 6. = Severe opiate withdrawal symptoms 7. = The most severe opiate withdrawal symptoms that I have ever had SIDE EFFECTS INDEX (Scale B): 1. = None. The study drug has no
Day 2
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Opiate Withdrawal Averages: | 1 | |
| Placebo Severity of Opiate Withdrawal Averages: | 1.33 | ± 0.471 |
| Lofexidine Side Effects Index Averages: | 1 | |
| Placebo Side Effects Index Averages: | 1 | ± NA |
Day 3
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Opiate Withdrawal Averages: | 1 | |
| Placebo Severity of Opiate Withdrawal Averages: | 1 | ± NA |
| Lofexidine Side Effects Index Averages: | 1 | |
| Placebo Side Effects Index Averages: | 1 | ± NA |
Day 4
| Group | Value | 95% CI |
|---|---|---|
| Placebo Severity of Opiate Withdrawal Averages: | 2 | ± NA |
| Placebo Side Effects Index Averages: | 2 | ± NA |
Day 5
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Opiate Withdrawal Averages: | 1 | |
| Placebo Severity of Opiate Withdrawal Averages: | 1.66 | ± 0.471 |
| Lofexidine Side Effects Index Averages: | 1 | |
| Placebo Side Effects Index Averages: | 1.66 | ± 0.471 |
Day 6
| Group | Value | 95% CI |
|---|---|---|
| Placebo Severity of Opiate Withdrawal Averages: | 2 | ± NA |
| Placebo Side Effects Index Averages: | 1.66 | ± 0.471 |
Day 7
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Opiate Withdrawal Averages: | 1 | |
| Placebo Severity of Opiate Withdrawal Averages: | 1.66 | ± 0.471 |
| Lofexidine Side Effects Index Averages: | 1 | |
| Placebo Side Effects Index Averages: | 1.66 | ± 0.471 |
Day 8
| Group | Value | 95% CI |
|---|---|---|
| Lofexidine Severity of Opiate Withdrawal Averages: | 1 | |
| Placebo Severity of Opiate Withdrawal Averages: | 2 | ± NA |
| Lofexidine Side Effects Index Averages: | 1 | |
| Placebo Side Effects Index Averages: | 2 | ± NA |
Day 9
| Group | Value | 95% CI |
|---|---|---|
| Placebo Severity of Opiate Withdrawal Averages: | 1.66 | ± 0.471 |
| Placebo Side Effects Index Averages: | 1.66 | ± 0.471 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 of drug administration through 30 day follow up, up to 57 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lofexidine
Serious: 0/1 (0%)
Deaths: 0/1
Placebo
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (5 terms — click to expand)
| Reaction | System | Lofexidine | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Sneezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Yawning | Respiratory, thoracic and mediastinal disorders | — | — |
| Lethargy | Nervous system disorders | — | — |
Data from ClinicalTrials.gov NCT04070157 adverse events section.
Sponsor's own description
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
New directions in the treatment of opioid withdrawal.
Srivastava AB, Mariani JJ, Levin FR. · · 2020 · cited 90× · PMID 32563380 · DOI 10.1016/s0140-6736(20)30852-7
Verify or expand the search:
- PubMed search for NCT04070157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Opioid Withdrawal (Disorder)
Currently open trials in the same condition.
- NCT07079215 — Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms · NA · recruiting
Other USWM, LLC (dba US WorldMeds) trials
Trials by the same sponsor.
- NCT04188730 — A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidi · Phase 1 · completed
- NCT05993299 — Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04070157 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by USWM, LLC (dba US WorldMeds)
- Last refreshed: 21 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04070157.
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