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Phase III study of lofexidine (DIMATEX) dosing regimens for opioid withdrawal during detoxification
2011-004775-36Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2011
- Countries
- 1
- Sponsor
- GET Group
- Modality
- Small Molecules
- Drugs
- lofexidine
- Conditions
- opioid use disorder (OUD)opioid withdrawal
01
Overview
Phase 3, open-label, single-arm trial of lofexidine in opioid use disorder (OUD) and opioid withdrawal, sponsored by GET Group. Primary endpoints: Adverse events, Withdrawal symptoms by SOWS and 1 more. Started Dec 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Different lofexidine dosage regimens
Participants received open-label lofexidine hydrochloride during opioid detoxification.
03
Who it enrols
Adults aged 18 to 60 years with DSM-IV heroin addiction, either entering rapid detoxification or undergoing drug-free detoxification from heroin or low-dose methadone, buprenorphine, or buprenorphine/naloxone, with urine positive for heroin and synthetic opioids and negative for other drugs. Key exclusions included hypotension, clinically significant cardiac disease, diabetes mellitus, significant liver disease, active treated HBV/HCV infection, chronic treated asthma, severe psychiatric disorders, epilepsy or recent anticonvulsant use, and gastrointestinal disorders affecting drug absorption.
04
Endpoints
Primary
Adverse events
Withdrawal symptoms by SOWS
Craving by VAS
Secondary
Treatment completion
Relapse during follow-up
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