Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3

NCT00000354

COMPLETED PHASE1

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

NCT00000358

COMPLETED PHASE1

Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal

NCT04218240

Opioid Withdrawal

COMPLETED PHASE2

Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal

NCT01863186

Opioid Dependence Acute Opioid Withdrawal Syndrome

COMPLETED PHASE3

Lofexidine for Opiate Withdrawal - 1

NCT00032942

Opioid-Related Disorders

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal. It follows a UG3 study in which 90 inpatients with an OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were equally safe, and that lofexidine/pregabalin was more effective in reducing subjective withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin.

The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient settings.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opiate Withdrawal Syndrome Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active pregabalin plus lofexidine versus placebo pregabalin plus lofexidine

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind placebo-controlled randomized trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LFX/PGB

PGB/day 1=400mg, day 2-7=600mg each day, day 8=400mg, day 9=200mg, day 10=100mg

LFX/day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg

Group Type EXPERIMENTAL

LFX/PGB

Intervention Type DRUG

lofexidine tablets 0.18mg tabs

pregabalin capsules 100mg and 25mg

LFX/PLA-PGB

Intervention Type DRUG

lofexidine tablets 0.18mg tabs

pregabalin capsules 0mg

LFX/PLA-PGB

PLA-PGB/day 1-7= 0mg each day, day 8, 9, and 10 =0mg each day

LFX/ day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg

Group Type ACTIVE_COMPARATOR

LFX/PGB

Intervention Type DRUG

lofexidine tablets 0.18mg tabs

pregabalin capsules 100mg and 25mg

LFX/PLA-PGB

Intervention Type DRUG

lofexidine tablets 0.18mg tabs

pregabalin capsules 0mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LFX/PGB

lofexidine tablets 0.18mg tabs

pregabalin capsules 100mg and 25mg

Intervention Type DRUG

LFX/PLA-PGB

lofexidine tablets 0.18mg tabs

pregabalin capsules 0mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lucemyra lyrica Lucemyra placebo pregabalin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male and/or female subjects ≥ 18 years of age
2. Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months
3. Interested in opioid antagonist treatment
4. Used opioids in 20 or more of the last 30 days
5. A stable address in the local area; not planning to move in the next 60 days.
6. Have documents for ID check
7. Absence of medical or psychiatric conditions that are likely to interfere with study participation
8. Has 12 lead ECG demonstrating a QTc ≤450 msec and a QRS ≤120 msec. Site PI has final determination for study inclusion if readings exceed these limits. The PENN cardiologists and medical monitor are available for consultation when needed
9. Negative pregnancy test and using adequate contraception if of childbearing potential.

Exclusion Criteria

1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission
2. Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
3. Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
4. Pending incarceration or plans to leave the immediate area in the next 30 days
5. Homicidal or otherwise behaviorally disturbed requiring immediate attention
6. High risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS
7. Blood pressure \<90 mm Hg (systolic) or \<60 mm Hg (diastolic). If value out of normal range, the investigator and study Clinician will decide subject inclusion/exclusion on case-by-case basis
8. Heart rate and/or pulse\<50 bpm at screening-sitting
9. An Estimated Glomerular Filtration Rate eGFR\<70 mL/min/1.73m2
10. A History of, or current Seizure disorder (excluding childhood febrile seizures)
11. 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
12. 12\. Pregnant or breastfeeding
13. 13\. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
14. ALT and/or AST \>4X upper limit of normal
15. A Child-Pugh score \>7
16. Currently receiving opioids for pain management
17. In a treatment study where medication was administered in the last 30 days
18. 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
19. In a methadone maintenance or buprenorphine treatment program within the last 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes