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A Study of Thienorphine Hydrochloride Tablets in Relapse Prevention Treatment of Opioid Dependence

NCT03656120 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-09-04

No results posted yet for this study

Summary

Opioid addiction is common worldwide. Thienorphine hydrochloride is a newly partial opioid receptor agonist drugs. It's affinity with opioid receptors was much higher than opioids, which could effectively prevents opioid dependence by stop opioids competition for opioid receptors and causing opioid dependence. The aim of this research was to determine whether thienorphine hydrochloride would reduce opioid use and better preventing relapse among opioid addicts.

Conditions

  • Opioid Dependence

Interventions

DRUG

0.2mg group

Thienorphine hydrochloride dose was set as 0.2mg per day,last for 12 weeks.

DRUG

0.5mg group

Thienorphine hydrochloride dose was set as 0.2mg per day for the first week and increased to 0.5mg per day from the second week, last for 11 weeks.

DRUG

placebo control group

Participants only take placebos for 12 weeks during the research.

Sponsors & Collaborators

  • Beijing ziduhongye technology development co. LTD

    collaborator UNKNOWN

  • Institute of Pharmacology and Toxicology, Academy of Military Medical Science

    collaborator UNKNOWN

  • Shanghai Mental Health Center

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Wuhan Mental Health Centre

    collaborator OTHER

  • Wei Hao

    lead OTHER

Principal Investigators

  • Weri Hao, Doctor · The Second Xiangya Hospital，Central South University, Changsha, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2019-08-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656120 on ClinicalTrials.gov