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Opioid DependencePhase 2NCT03656120

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

A Phase 2 study testing 0.2mg group and 0.5mg group in people with Opioid Dependence, run by Wei Hao.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Opioid Dependence
What is being tested?
0.2mg group and 0.5mg group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
No sites listed yet
Study dates
31 Aug 2018to 31 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Wei Hao, Doctor contact

8613907484086

weihao57@163.com

About this study

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

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.

Read the 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.

Being tested
0.2mg group, 0.5mg group, placebo control group
Keywords
opioid dependence, thienorphine hydrochloride
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.2mg groupDrug

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

  • 0.5mg groupDrug

    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.

  • placebo control groupDrug

    Participants only take placebos for 12 weeks during the research.

Study groups in NCT03656120
Study groupRoleWhat they receive
0.2mg groupExperimentalParticipants are taking 0.2mg thienorphine hydrochloride table once a day for 12 weeks.
Receives: Drug: 0.2mg group
0.5mg groupExperimentalParticipants are taking 0.5mg thienorphine hydrochloride table once a day for 12 weeks.
Receives: Drug: 0.5mg group
placebo control groupPlacebo comparatorParticipants only taking placebo once a day for 12 weeks.
Receives: Drug: placebo control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 12 weeks

Secondary outcomes (6)

  1. 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.

    Measured: up to 12 weeks

  2. 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).

    Measured: up to 12 weeks

  3. 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).

    Measured: up to 12 weeks

  4. 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.

    Measured: up to 12 weeks

  5. 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.

    Measured: up to 12 weeks

  6. 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.

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start31 Aug 2018 (estimated)
  3. Primary completion31 Aug 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03656120
Sponsor's protocol ID
100000-068945
Status last verified
Aug 2018
First submitted
29 Aug 2018
Last updated
4 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.2mg group and 0.5mg group in people with Opioid Dependence, run by Wei Hao.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Hao, Doctor (8613907484086, weihao57@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

days of retention in outpatient treatment (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.

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