Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Pennsylvania
Study ID
NCT05995535
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • LFX/PGB — DRUG
    lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg
  • LFX/PLA-PGB — DRUG
    lofexidine tablets 0.18mg tabs pregabalin capsules 0mg

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: 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

Primary Outcome Measure

Subjective Opioid Withdrawal Scale (SOWS) scores [ Time Frame: 10 days per subject, through study completion (N=150) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mountain Manor Treatment CenterBaltimoreMaryland21229-3618
Marc Fishman, MD
[email protected]
4102331400
kevin Wenzel
[email protected]
4102331400
Marc Fishman, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania, Treatment Research CenterPhiladelphiaPennsylvania19104
Kyle Kampman, MD
[email protected]
(215)222-3200
Sabrina A Poole, PsyD
[email protected]
2157468802
Kyle M Kampman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Mountain Manor Treatment Center· Baltimore, MDUniversity of Pennsylvania, Treatment Research Center· Philadelphia, PA

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