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

NCT03656120 | Unknown Phase 2

• 1 other identifier: 100000-068945
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

opioid dependence; thienorphine hydrochloride

Outcome Measures

Primary Outcomes (1)

• days of retention in outpatient treatment

  Primary outcome measure was retention time of each participants during these 12 weeks, defined as from the beginning of randomized into assigned group to the days participants decided to quit the research for the following reasons: (1) Subjects were not receiving assigned therapy for seven consecutive days or more; (2) the subject cannot continue to participate in the study for other reasons; (3) The researchers decided that the subject should stop the study based on their clinical diagnosis and treatment; (4) subjects withdrew their consent form.

  up to 12 weeks

Secondary Outcomes (6)

• opioids negative rate through urine test

  up to 12 weeks

• Change of withdrawal score of Clinical Opioid Withdrawal Symptom Scale (COWS) from baseline to 12 weeks

  up to 12 weeks

• Change of craving from baseline in Visual Analog Scale (VAS) at 12 weeks

  up to 12 weeks

• Change of self-reported euphoria after using heroin

  up to 12 weeks

• Subjects ' overall evaluation of efficacy of relapse prevention treatment of thienorphine hydrochloride tablets

  up to 12 weeks

Study Arms (3)

0.2mg group

EXPERIMENTAL

Participants are taking 0.2mg thienorphine hydrochloride table once a day for 12 weeks.

Drug: 0.2mg group

0.5mg group

EXPERIMENTAL

Participants are taking 0.5mg thienorphine hydrochloride table once a day for 12 weeks.

Drug: 0.5mg group

placebo control group

PLACEBO COMPARATOR

Participants only taking placebo once a day for 12 weeks.

Drug: placebo control group

Interventions

0.2mg group DRUG

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

0.2mg group

0.5mg group DRUG

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.

0.5mg group

placebo control group DRUG

Participants only take placebos for 12 weeks during the research.

placebo control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently meets the diagnostic criteria for DSM-IV opioid dependence, with a history of opioids using more than 1 year; having relapsed for opioids for at least twice, and meets one of the following criterion:
• Opioid dependent patients (including heroin dependent patients or patients undergoing methadone maintenance treatment) treated with buprenorphine and meeting the following criteria: 1.1.1 Taking buprenorphine 2 mg per day for at least 3 consecutive days; 1.1.2 Clinical Opioid Withdrawal Symptom Scale (COWS) score ≤ 4; 1.1.3 Negative urine test results for morphine and methadone; 1.2 Having been stopped to using opioids. Negative urine test results for morphine, methadone and buprenorphine. As well as negative result for naloxone-precipitated tests ((including patients returning to the community from drug rehabilitation agencies).
• Age 18 to 60 years old, male and female
• Weight 40 \~ 95kg
• Able to communicate with researchers, willing to receive anti-relapse therapy, and provide signed consent forms.

You may not qualify if:

• Substance dependence other than nicotine;
• Severe psychiatric disorders;
• Severe physical illnesses, including severe digestive, cardiovascular, respiratory, and endocrine systems problems;
• Patients with severe chronic pain;
• Women in pregnancy or lactation
• Patients who do not have effective contraception methods
• Systolic/diastolic pressure is higher than 150/100mmHg or lower than 85/60mmHg
• Heart rate \<50 beats / min;
• Severe liver or kidney dysfunction or severe abnormalities confirmed by laboratory test (liver function indicators ALT, AST are more than 3 times higher than the upper limit of normal values; any of the renal function indicators BUN, Cr that is higher than the upper limit of normal 1.5 times and above);
• Allergic to buprenorphine or other similar drugs;
• Patients with dysuria or urinary retention symptoms;
• People with severe habitual constipation;
• Those with HIV infection;
• Poor adherence;
• Participants enrolled in other clinical trials within 4 weeks prior to enrollment.

Sponsors & Collaborators

• Wei Hao: lead
• Beijing ziduhongye technology development co. LTD: collaborator
• Institute of Pharmacology and Toxicology, Academy of Military Medical Science: collaborator
• Shanghai Mental Health Center: collaborator
• West China Hospital: collaborator
• Wuhan Mental Health Centre: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Weri Hao, Doctor

  The Second Xiangya Hospital，Central South University, Changsha, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Hao, Doctor

CONTACT

8613907484086; weihao57@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director, Institute of Mental Health, Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 4, 2018
• Study Start: August 31, 2018
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 4, 2018

Record last verified: 2018-08