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

China Medical University

Status and phase: Completed; Phase 2

Conditions: Opiate Dependence

Treatments: Drug: Suan-Zao-Ren Tang placebo; Drug: Suan-Zao-Ren Tang

Study type: Interventional

Funder types: Other

Identifiers

NCT01913418

NSC 102-2320-B-039-024-

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 2 patient groups, including a placebo group

Suan-Zao-Ren Tang

Active Comparator group

Description:

The 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.

Treatment:

Drug: Suan-Zao-Ren Tang

Suan-Zao-Ren Tang placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Suan-Zao-Ren Tang placebo