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Opiate DependencePhase 2NCT01913418

Clinical Efficacy and Serum Proteomic Profiling of Suan-Zao-Ren Tang for Sleep Disturbance During Methadone Maintenance

A Phase 2 study testing Suan-Zao-Ren Tang in people with Opiate Dependence, run by China Medical University, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving sleep quality, anxiety, depression, and heroin craving among methadone-maintained persons with sleep complaints. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Opiate Dependence
What is being tested?
Suan-Zao-Ren Tang
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteTaiwan
Study dates
Jul 2013to Mar 2014
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged over 20 years
  • patients fulfilled the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence
  • patients had been receiving MMT for more than one month
  • patients have sleep disturbance complains and with Pittsburgh sleep quality index (PSQI) of greater than six
  • Must be able to signed informed consent

Who cannot join

  • had received any antidepressant or neuroleptic medication
  • had received any TCM treatment during the previous 30 days
  • had any serious physical or mental illness
  • had a significant risk of suicide
  • pregnancy
  • inability to read and fill out the forms for the study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan

    Taoyuan, 325

Other trials in Taiwan

About this study

Official title: Clinical Efficacy and Serum Proteomic Profiling of Traditional Chinese Medicine, Suan-Zao-Ren Tang, for Sleep Disturbance During Methadone Maintenance: Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial

The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving sleep quality, anxiety, depression, and heroin craving among methadone-maintained persons with sleep complaints.

Read the detailed description

Background:

Heroin dependence is one of the major health issues worldwide. Methadone Maintenance Therapy (MMT) is an effective treatment for opioid dependence, but more than three quarters of persons receiving MMT report sleep complaints. Traditional Chinese Medicine (TCM) is one of the most common complementary therapies offered to insomnia patients in Taiwan. Investigators designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TCM in methadone-maintained persons with sleep disturbance.

Methods/design:

In this study, inclusion criteria are persons receiving MMT for at least one month, more than 20 years old, complain insomnia with a Pittsburgh Sleep Quality Index (PSQI) of six or higher. Exclusion criteria include being pregnancy, had serious physical or mental illness, current use (last 30 days) of TCM, had received any antidepressant or neuroleptic medication and inability to read and fill out the forms for the study. The patients were separated into an intervention group (Suan-Zao-Ren Tang, SZRT) and a placebo group for four weeks using a randomized, double-blind procedure. Outcome measures will be assessed at baseline, 4 weeks and 8 weeks after receiving medication. PSQI was used to assess sleep quality over the past 30 days, anxiety and depression levels measured by the Beck Anxiety Inventory (BAI) and Beck Depression Inventory II (BDI-II) were also conducted, heroin craving degree was evaluated by the change of the visual analog scale (VAS). Serum proteins will be detected using a proteomics method based on two-dimensional gel electrophoresis, and the specificity of proteins will confirmed by western blotting. T-test and chi-square tests are used for statistical analysis.

Discussion:

SZRT is a combination of Semen Zizyphi Spinosae (Suanzaoren), Sclerotium Poriae Cocos (Fuling), Radix Ligustici Chuanxiong (Chuanxiong), Rhizoma Anemarrhena (Zhimu), and Radix Glycyrrhizae (Gancao). It was the most commonly prescribed Chinese herbal formula used for the treatment of insomnia. In the classical literature and previous studies, SZRT was said to calm the nerves and nourish the blood to eventually bring on a tranquillizing sensation and improved the quality of sleep without generating significant side effects. In order to evaluate the efficacy of SZRT for sleep disturbance during methadone maintenance, investigators designed a randomized, double-blind, placebo-controlled trial and perform the proteomic-system biology analysis to find the biomarker associated with sleep condition.

Being tested
Suan-Zao-Ren Tang, Suan-Zao-Ren Tang placebo
Keywords
Traditional Chinese Medicine, Suan-Zao-Ren Tang, Methadone, Opiate dependence, Sleep
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.

  • Suan-Zao-Ren TangDrug

    SZRT is composed of five herb ingredients as follows: Semen Zizyphi Spinosae (Suanzaoren), Sclerotium Poriae Cocos (Fuling), Radix Ligustici Chuanxiong (Chuanxiong), Rhizoma Anemarrhena (Zhimu), and Radix Glycyrrhizae (Gancao).The SZRT granules were packed in aluminum foil packages and administered orally at a dose of 4 g, three times per day for four weeks.

  • Suan-Zao-Ren Tang placeboDrug

    The Suan-Zao-Ren Tang placebo granules are prepared with 4 g starch inside the same colored and sized foil packages.

Study groups in NCT01913418
Study groupRoleWhat they receive
Suan-Zao-Ren TangActive comparatorThe SZRT formula used in this study is manufactured as a herbal extract powder from the good manufacturing procedures (GMP) of the certified company Kaiser Pharmaceutical Co., Ltd. (Taiwan). Granules were packed in aluminum foil packages and administered orally at a dose of 4 g, three times per day for four weeks.
Receives: Drug: Suan-Zao-Ren Tang
Suan-Zao-Ren Tang placeboPlacebo comparatorThe Suan-Zao-Ren Tang placebo granules are prepared with 4 g starch inside the same colored and sized foil packages.
Receives: Drug: Suan-Zao-Ren Tang placebo

What is being measured

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

  1. sleep quality

    The primary outcome measure under study is the sleep quality. Sleep quality will be assessed using the Taiwanese version of the PSQI, which has demonstrated reliability and validity. It evaluates sleep disturbances in 7subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. Each subscale is rated on a 4-point scale (0 to 3, with 3 indicating a more profound effect), which is summed together to yield a global score (0to21).

    Measured: The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).

Secondary outcomes (3)

  1. severity of heroin craving

    The severity of heroin craving was assessed using a 100 millimeters visual analog scale (VAS).

    Measured: The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).

  2. Beck Anxiety inventory (BAI)

    This measure lists 21 symptoms of anxiety such as feeling hot, scared or nervous. Participants will be instructed to rate how much each of these symptoms bothered them in the past week. Each item can be rated on a 4 point Likert scale, ranging from 0 (Not at all) to 3 (Severely) yielding a maximum total score of 63 points.

    Measured: The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).

  3. Beck Depression Inventory (BDI-II, second edition)

    Depression symptoms will be measured with the BDI-II. This measure consists of 13 items to evaluate depression, and each item is rated from 0 to 3 according to the degree by which it reflects a patient's state during the previous week. The BDI has a high reliability, and concurrent validity.

    Measured: The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).

Timeline

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

  1. First posted1 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01913418
Sponsor's protocol ID
NSC 102-2320-B-039-024-
Status last verified
Mar 2014
First submitted
28 Jul 2013
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Suan-Zao-Ren Tang in people with Opiate Dependence, run by China Medical University, Taiwan at 1 site in Taiwan.

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 6 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: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep quality (time frame: The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).). 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 NCT01913418.

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 18 Mar 2014.

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