Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

NCT05995535 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 854046
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Opiate Withdrawal Syndrome; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Subjective Opioid Withdrawal Scale (SOWS) scores

  Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal

  10 days per subject, through study completion (N=150)

Secondary Outcomes (2)

• Study detox completion

  10 days per subject, through study completion (N=150)

• XR-NTX IM injection

  upto 2 days per subject (N=150)

Study Arms (2)

LFX/PGB

EXPERIMENTAL

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

Drug: LFX/PGB; Drug: LFX/PLA-PGB

LFX/PLA-PGB

ACTIVE COMPARATOR

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

Drug: LFX/PGB; Drug: LFX/PLA-PGB

Interventions

LFX/PGB DRUG

lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg

Also known as: Lucemyra, lyrica

LFX/PGB; LFX/PLA-PGB

LFX/PLA-PGB DRUG

lofexidine tablets 0.18mg tabs pregabalin capsules 0mg

Also known as: Lucemyra, placebo pregabalin

LFX/PGB; LFX/PLA-PGB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female subjects ≥ 18 years of age
• 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
• Interested in opioid antagonist treatment
• Used opioids in 20 or more of the last 30 days
• A stable address in the local area; not planning to move in the next 60 days.
• Have documents for ID check
• Absence of medical or psychiatric conditions that are likely to interfere with study participation
• Negative pregnancy test and using adequate contraception if of childbearing potential.

You may not qualify if:

• Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission
• Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
• Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
• Pending incarceration or plans to leave the immediate area 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
• Heart rate and/or pulse\<50 bpm at screening-sitting
• An Estimated Glomerular Filtration Rate eGFR\<70 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
• ALT and/or AST \>4X upper limit of normal
• A Child-Pugh score \>7
• Currently receiving opioids for pain management

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Mountain Manor Treatment Center

Baltimore, Maryland, 21229-3618, United States

NOT YET RECRUITING

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

lofexidine; Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Kyle M Kampman, MD

CONTACT

215-746-2764; Kampman@pennmedicine.upenn.edu

Matthew R Taylor

CONTACT

215-746-0467; matthew.taylor@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind placebo-controlled randomized trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Model Details: Active pregabalin plus lofexidine versus placebo pregabalin plus lofexidine

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 16, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)