Trial · NCT04218240
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
NCT04218240, Phase 2, Completed, University of Pennsylvania; results first posted 2024-05-20
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal. Trials, record NCT04218240. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04218240
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
- NCT number
- NCT04218240
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Opioid Withdrawal
- Interventions
- Pregabalin 200 MG capsules, Placebo oral tablet, Lofexidine 0.18Mg Tab
- First posted
- 2020-01-06
- Last updated
- 2024-09-19
- Results first posted
- 2024-05-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score | 7 days | mild = 1-10 moderate=11-20 severe=21-30 higher number equals worse score |
| Secondary | Completion of Withdrawal Management | 7 days | proportion of participants who completed the 7-day detoxification |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score | 7 days | males, females 18+ years of age, opioid use disorder | score on a scale | MEAN |
| SECONDARY | Completion of Withdrawal Management | 7 days | male, females 18+ years of age, opioid Use diagnosis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score | PGB/LFX; | 7.0 | Standard Deviation 4.6 | score on a scale | |
| Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score | Lofexidine and PLACEBO | 9.1 | Standard Deviation 5.1 | score on a scale | |
| Completion of Withdrawal Management | PGB/LFX; | completed detox | 23 | Participants | |
| Completion of Withdrawal Management | Lofexidine and PLACEBO | completed detox | 9 | Participants | |
| Completion of Withdrawal Management | PGB/LFX; | did not complete detox | 35 | Participants | |
| Completion of Withdrawal Management | Lofexidine and PLACEBO | did not complete detox | 23 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PGB/LFX; | 58 | |
| Overall Study | STARTED | Lofexidine and PLACEBO | 32 | |
| Overall Study | COMPLETED | PGB/LFX; | 24 | |
| Overall Study | COMPLETED | Lofexidine and PLACEBO | 11 | |
| Overall Study | NOT COMPLETED | PGB/LFX; | 34 | |
| Overall Study | NOT COMPLETED | Lofexidine and PLACEBO | 21 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | bradycardia | Vascular disorders | PGB/LFX; | 10 | 58 | 12 |
| other | bradycardia | Vascular disorders | Lofexidine and PLACEBO | 7 | 32 | 9 |
| other | dizziness | Nervous system disorders | PGB/LFX; | 8 | 58 | 8 |
| other | dizziness | Nervous system disorders | Lofexidine and PLACEBO | 8 | 32 | 8 |
| other | orthostatic hypotension | Cardiac disorders | PGB/LFX; | 31 | 58 | 64 |
| other | orthostatic hypotension | Cardiac disorders | Lofexidine and PLACEBO | 20 | 32 | 42 |
| other | sedation | Nervous system disorders | PGB/LFX; | 12 | 58 | 13 |
| other | sedation | Nervous system disorders | Lofexidine and PLACEBO | 6 | 32 | 6 |
| serious | nausea with vomiting | Gastrointestinal disorders | PGB/LFX; | 0 | 58 | 0 |
| serious | nausea with vomiting | Gastrointestinal disorders | Lofexidine and PLACEBO | 1 | 32 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PGB/LFX; | 0 | 58 |
| Total, all-cause mortality | Lofexidine and PLACEBO | 0 | 32 |
| Total, other adverse events | PGB/LFX; | 36 | 58 |
| Total, other adverse events | Lofexidine and PLACEBO | 26 | 32 |
| Total, serious adverse events | PGB/LFX; | 0 | 58 |
| Total, serious adverse events | Lofexidine and PLACEBO | 1 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG3DA049694 | Combining Pregabalin with Lofexidine: Can it Increase the Success of Transition to Naltrexone? | KAMPMAN, KYLE MATTHEW; WOODY, GEORGE EDWARD | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE ON DRUG ABUSE | 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PGB/LFX; vs Lofexidine and PLACEBO: deaths from any cause | Trial comparisons |
| PGB/LFX; vs Lofexidine and PLACEBO: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04218240
GET https://conductscience.org/api/trials/v1/NCT04218240/registered