Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal

Conditions

• Opioid Withdrawal (Disorder)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lofexidine — DRUG
  Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
• Placebo — DRUG
  Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.

Study Details

Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.

Key Dates

First listed

Aug 28, 2019

Start date

Aug 2, 2019

Status verified

Oct 2024

Primary completion

Nov 27, 2019

Completion

Nov 27, 2019

Study Design

Enrollment

4 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lofexidine
• Placebo Comparator: Placebo

Primary Outcome Measure

Number of Treatment Emergent AEs and SAEs [ Time Frame: Day 1 through Day 28 ]

Locations (12)

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