Opioid WithdrawalPhase 2PGB-LOFNCT04218240
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
A Phase 2 study testing Pregabalin 200 MG capsules and Lofexidine 0.18Mg Tab in people with Opioid Withdrawal, run by University of Pennsylvania at 3 sites in United States.
Trial summary
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid Withdrawal
- What is being tested?
- Pregabalin 200 MG capsules and Lofexidine 0.18Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2020to 31 Aug 2023
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female subjects ≥ 18 years of age
- Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have 2 or more of the 11 DSM 5 criteria for opioid disorder including tolerance and withdrawal features in the last 12 months
- Interested in opioid antagonist treatment
- Have used opioids in 20 or more of the last 30 days
- Have a stable address in the local area; not planning to move; have documents for ID check
- Absence of medical or psychiatric conditions that are likely to interfere with study participation
- Have a 12 lead ECG demonstrating a QTc ≤450 msec and a QRS interval ≤120 msec. The site PI has the final determination for inclusion into the study for ECGs unless there is a question of QT prolongation or other factors (QTc/Fre uses the Frederica formula (QTc = QT/RR(1/3)). If consultation is needed, the PENN cardiologists and the medical monitor should be contacted
- If female, have a negative pregnancy test and uses adequate contraception if of childbearing potential
Who cannot join
- Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
- An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
- History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
- Pending incarceration in the next 30 days
- Homicidal or otherwise behaviorally disturbed requiring immediate attention.
- High Risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS at screening
Show all 19Show fewer
- Blood pressure <90 mm Hg (systolic) or <60 mm Hg (diastolic). If this value is out of normal range, the investigator and a study clinician will decide subject inclusion or exclusion on a case-by-case basis
- Heart rate and/or pulse<50 bpm at screening-sitting
- An Estimated Glomerular Filtration Rate eGFR<90 mL/min/1.73m2
- A History of, or current Seizure disorder (excluding childhood febrile seizures)
- Inability to read and/or understand English. For example, unable to understand the informed consent as demonstrated by failing to answer 9/10 questions correctly on the quiz
- Pregnant or breastfeeding
- Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
- An ALT and/or AST test that is at >4X the top limit of normal
- A Child-Pugh score >7
- Currently receiving opioids for pain management
- In a treatment study where medication was administered in the last 30 days
- Currently using medications that are known to be strong or moderate inhibitors of CYP2D6 such as fluoxetine, paroxetine, mirabegron, bupropion, quinidine, terbinafine, cimetidine, cinacalcet, duloxetine, or fluvoxamine
- In a methadone maintenance or buprenorphine treatment program within the last 30 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
John Mariani
New York, New York, 10019
Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of patients with an opioid use disorder (OUD) who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone (XR-NTX).
Read the detailed description
An inpatient detoxification study where pregabalin (PBG) will be given orally at a starting dose of up to 600 mg daily (group 1) tapered to 100 mg daily over 7 days; given with lofexidine (LFX) starting at 2.16 mg daily and declining to 0.72 mg over 7 days. On day 8, subjects are offered an injection of XR-NTX if they provide a urine sample that is negative for opioids and buprenorphine and pass a naloxone challenge. All subjects, regardless of whether or not they receive XR-NTX, will be given a referral and appointment for follow-up treatment when they leave the inpatient detoxification program.
- Conditions
- Opioid Withdrawal
- Being tested
- Pregabalin 200 MG capsules, Placebo oral tablet, Lofexidine 0.18Mg Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 200 MG capsulesDrug
Also called lyrica
oral pregabalin 200 mg capsules given with a taper on day 5
Placebo oral tabletDrug
oral Placebo
Lofexidine 0.18Mg TabDrug
Also called lucemyra
lofexidine 0.18 tab given with a taper starting on day 5
| Study group | Role | What they receive |
|---|---|---|
| PGB/LFX; | Experimental | 0.54 mg lofexidine and 200 mg Pregabalin on days 1 -7 with taper for pregabalin and lofexidine starting on day 5 Receives: Drug: Pregabalin 200 MG capsules; Drug: Lofexidine 0.18Mg Tab |
| Lofexidine and PLACEBO | Active comparator | 0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5 Receives: Drug: Placebo oral tablet; Drug: Lofexidine 0.18Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score
mild = 1-10 moderate=11-20 severe=21-30 higher number equals worse score
Measured: 7 days
Secondary outcomes (1)
Completion of Withdrawal Management
proportion of participants who completed the 7-day detoxification
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start17 Dec 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- for the primary comparison of longitudinal subjective withdrawal measures, comparing the groups on rate of decrease across detox days, using a linear group by time effect for the mixed effects models described above. We have one primary outcome, so use an alpha level of 0.05, and we use two-sided tests. 90 subjects, 30 from each of three sites, who will be randomized into two groups, with 30 assigned to Lofexidine plus Placebo, and 60 to Lofexidine plus a starting daily dose of 400 mg of pregabalin and increasing to 600mg Pregabalin on day 2.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Kampman, University of Pennsylvania
- Investigators
- Stuart Watson, Study director, Office of Research Administration, Univ. of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218240
- Sponsor's protocol ID
- 1UG3DA049694-01
- Acronym
- PGB-LOF
- Status last verified
- May 2024
- First submitted
- 2 Jan 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not at this time
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?
- ClinicalTrials.gov ID
- NCT04218240
- Acronym / sponsor ID
- PGB-LOF / 1UG3DA049694-01
- Conditions
- Opioid Withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of patients with an opioid use disorder (OUD) who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone (XR-NTX).
Detailed description
An inpatient detoxification study where pregabalin (PBG) will be given orally at a starting dose of up to 600 mg daily (group 1) tapered to 100 mg daily over 7 days; given with lofexidine (LFX) starting at 2.16 mg daily and declining to 0.72 mg over 7 days. On day 8, subjects are offered an injection of XR-NTX if they provide a urine sample that is negative for opioids and buprenorphine and pass a naloxone challenge. All subjects, regardless of whether or not they receive XR-NTX, will be given a referral and appointment for follow-up treatment when they leave the inpatient detoxification program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- for the primary comparison of longitudinal subjective withdrawal measures, comparing the groups on rate of decrease across detox days, using a linear group by time effect for the mixed effects models described above. We have one primary outcome, so use an alpha level of 0.05, and we use two-sided tests. 90 subjects, 30 from each of three sites, who will be randomized into two groups, with 30 assigned to Lofexidine plus Placebo, and 60 to Lofexidine plus a starting daily dose of 400 mg of pregabalin and increasing to 600mg Pregabalin on day 2.
| Arm | Type | Receives |
|---|---|---|
| PGB/LFX; | Experimental | Drug: Pregabalin 200 MG capsules, Drug: Lofexidine 0.18Mg Tab0.54 mg lofexidine and 200 mg Pregabalin on days 1 -7 with taper for pregabalin and lofexidine starting on day 5 |
| Lofexidine and PLACEBO | Active comparator | Drug: Placebo oral tablet, Drug: Lofexidine 0.18Mg Tab0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and/or female subjects ≥ 18 years of age
- Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have 2 or more of the 11 DSM 5 criteria for opioid disorder including tolerance and withdrawal features in the last 12 months
- Interested in opioid antagonist treatment
- Have used opioids in 20 or more of the last 30 days
- Have a stable address in the local area; not planning to move; have documents for ID check
Key exclusion criteria (19 listed)
- Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
- An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
- History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
- Pending incarceration in the next 30 days
- Homicidal or otherwise behaviorally disturbed requiring immediate attention.
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 |
|---|---|---|
| Pregabalin 200 MG capsulesAlso: lyricaoral pregabalin 200 mg capsules given with a taper on day 5 | Drug | PGB/LFX; |
| Placebo oral tabletoral Placebo | Drug | Lofexidine and PLACEBO |
| Lofexidine 0.18Mg TabAlso: lucemyralofexidine 0.18 tab given with a taper starting on day 5 | Drug | Lofexidine and PLACEBO, PGB/LFX; |
Primary outcome
Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score
Time frame: 7 days
mild = 1-10 moderate=11-20 severe=21-30 higher number equals worse score
1 secondary outcome
Completion of Withdrawal Management
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not at this time
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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.
Stuart Watson study director
Office of Research Administration, Univ. of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pregabalin 200 MG capsules and Lofexidine 0.18Mg Tab in people with Opioid Withdrawal, run by University of Pennsylvania at 3 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 8 inclusion and 19 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 May 2024). 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?
Subjective Opioid Withdrawal Scale-Gossop (SOWS) Scale Score (time frame: 7 days). 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 19 Sep 2024.