Back to resultsA Study of Thienorphine Hydrochloride Tablets in Relapse Prevention Treatment of Opioid Dependence
Primary Purpose
Opioid Dependence
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
0.2mg group
0.5mg group
placebo control group
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, thienorphine hydrochloride
Eligibility Criteria
Inclusion Criteria:
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:
1.1 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
0.2mg group
0.5mg group
placebo control group
Arm Description
Participants are taking 0.2mg thienorphine hydrochloride table once a day for 12 weeks.
Participants are taking 0.5mg thienorphine hydrochloride table once a day for 12 weeks.
Participants only taking placebo once a day for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
opioids negative rate through urine test
For each subject，opioids negative rate was defined as the number of negative urine test during the 12-week treatment divided by the number of urine tests each subject should performed at the end of the study. Missed test is treated positively by urine test.
Change of withdrawal score of Clinical Opioid Withdrawal Symptom Scale (COWS) from baseline to 12 weeks
Clinical Opioid Withdrawal Symptom Scale (COWS) is calculates as the change in the subject's COWS score over the 12-week period compared to baseline. COWS scale contains a total of 32 items, and the contents of the item basically cover all symptoms and signs of opioid withdrawal. Each symptom is divided into four levels, ranging from 0 (no symptoms at all) to 3 (severe symptoms).
Change of craving from baseline in Visual Analog Scale (VAS) at 12 weeks
A 10-point Visual Analog Scale (VAS) was used to assess subjective self-report craving for opioids, where the subject was asked to quantify his/her subjective state of craving for opioids by marking a point on a line which is anchored at one end by words describing an absence of the subjective craving state (0 point) and at the other end by words describing a maximal intensity of craving state (10 points).
Change of self-reported euphoria after using heroin
Within these 12 weeks, euphoria scores of subject lapsed to heroin are collect if the subject lapsed to heroin.
Subjects ' overall evaluation of efficacy of relapse prevention treatment of thienorphine hydrochloride tablets
At the end of the 12-week study, subjects are going to evaluate the overall treatment efficacy of thienorphine hydrochloride during these 12-week period using a five-point scale. The scale is divided into 5 levels: very good, good, fair, poor, and very poor.
Researchers' overall evaluation of efficacy of relapse prevention treatment of thienorphine hydrochloride tablets
At the end of the 12-week study, researchers are going to evaluate the overall treatment efficacy of thienorphine hydrochloride during these 12-week period using a five-point scale. The scale is divided into 5 levels: very good, good, fair, poor, and very poor.
Full Information
NCT ID
NCT03656120
First Posted
August 29, 2018
Last Updated
August 30, 2018
Sponsor
Wei Hao
Collaborators
Beijing ziduhongye technology development co. LTD, Institute of Pharmacology and Toxicology, Academy of Military Medical Science, Shanghai Mental Health Center, West China Hospital, Wuhan Mental Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT03656120
Brief Title
A Study of Thienorphine Hydrochloride Tablets in Relapse Prevention Treatment of Opioid Dependence
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅱb Clinical Trial of Thienorphine Hydrochloride Tablets for the Efficacy, Safety, and Optimal Dosing of Relapse Prevention After Opioid Dependence Detoxification
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2018 (Anticipated)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Hao
Collaborators
Beijing ziduhongye technology development co. LTD, Institute of Pharmacology and Toxicology, Academy of Military Medical Science, Shanghai Mental Health Center, West China Hospital, Wuhan Mental Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Opioids dependence is a chronic brain disease, with a much higher rate of relapse rate. Relapse prevention is important for opioid dependence treatment. Thienorphine hydrochloride, derivatives of buprenorphine, is one of the receptor partial agonists. Previous research indicated that, it may be a safe and effective treatment for the prevention of opioid dependent patients after detoxification. In this multicenter, randomized, double-blind, placebo-controlled, phase Ⅱb clinical trial, we are aimed to evaluate the efficacy of thienorphine hydrochloride tablets for anti-relapse therapy after opioid dependence detoxification treatment, determining the optimal dose of thienorphine hydrochloride tablets, and further evaluate the safety of thienorphine hydrochloride for patients with opioid dependence. 180 eligible patients are going to be recruited and randomly assigned to 0.2mg/day group, 0.5mg/day group and placebo control group after they provided their consent forms. Subjects in each group would receive assigned treatment for 12 weeks. Primary outcome measure was retention time of each participants during these 12 weeks. Urine test for opioids, changing of withdrawal score and craving, self-reported euphoria after using heroin, subjects and researchers' overall evaluation of treatment efficacy are secondary outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
opioid dependence, thienorphine hydrochloride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.2mg group
Arm Type
Experimental
Arm Description
Participants are taking 0.2mg thienorphine hydrochloride table once a day for 12 weeks.
Arm Title
0.5mg group
Arm Type
Experimental
Arm Description
Participants are taking 0.5mg thienorphine hydrochloride table once a day for 12 weeks.
Arm Title
placebo control group
Arm Type
Placebo Comparator
Arm Description
Participants only taking placebo once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
0.2mg group
Intervention Description
Thienorphine hydrochloride dose was set as 0.2mg per day,last for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
0.5mg group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo control group
Intervention Description
Participants only take placebos for 12 weeks during the research.
Primary Outcome Measure Information:
Title
days of retention in outpatient treatment
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
opioids negative rate through urine test
Description
For each subject，opioids negative rate was defined as the number of negative urine test during the 12-week treatment divided by the number of urine tests each subject should performed at the end of the study. Missed test is treated positively by urine test.
Time Frame
up to 12 weeks
Title
Change of withdrawal score of Clinical Opioid Withdrawal Symptom Scale (COWS) from baseline to 12 weeks
Description
Clinical Opioid Withdrawal Symptom Scale (COWS) is calculates as the change in the subject's COWS score over the 12-week period compared to baseline. COWS scale contains a total of 32 items, and the contents of the item basically cover all symptoms and signs of opioid withdrawal. Each symptom is divided into four levels, ranging from 0 (no symptoms at all) to 3 (severe symptoms).
Time Frame
up to 12 weeks
Title
Change of craving from baseline in Visual Analog Scale (VAS) at 12 weeks
Description
A 10-point Visual Analog Scale (VAS) was used to assess subjective self-report craving for opioids, where the subject was asked to quantify his/her subjective state of craving for opioids by marking a point on a line which is anchored at one end by words describing an absence of the subjective craving state (0 point) and at the other end by words describing a maximal intensity of craving state (10 points).
Time Frame
up to 12 weeks
Title
Change of self-reported euphoria after using heroin
Description
Within these 12 weeks, euphoria scores of subject lapsed to heroin are collect if the subject lapsed to heroin.
Time Frame
up to 12 weeks
Title
Subjects ' overall evaluation of efficacy of relapse prevention treatment of thienorphine hydrochloride tablets
Description
At the end of the 12-week study, subjects are going to evaluate the overall treatment efficacy of thienorphine hydrochloride during these 12-week period using a five-point scale. The scale is divided into 5 levels: very good, good, fair, poor, and very poor.
Time Frame
up to 12 weeks
Title
Researchers' overall evaluation of efficacy of relapse prevention treatment of thienorphine hydrochloride tablets
Description
At the end of the 12-week study, researchers are going to evaluate the overall treatment efficacy of thienorphine hydrochloride during these 12-week period using a five-point scale. The scale is divided into 5 levels: very good, good, fair, poor, and very poor.
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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:
1.1 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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Hao, Doctor
Phone
8613907484086
Email
weihao57@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weri Hao, Doctor
Organizational Affiliation
The Second Xiangya Hospital，Central South University, Changsha, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study of Thienorphine Hydrochloride Tablets in Relapse Prevention Treatment of Opioid Dependence
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