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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- sleep quality
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Suan-Zao-Ren Tang
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.
Intervention: Suan-Zao-Ren Tang (Drug)
Suan-Zao-Ren Tang placebo
The Suan-Zao-Ren Tang placebo granules are prepared with 4 g starch inside the same colored and sized foil packages.
Intervention: Suan-Zao-Ren Tang placebo (Drug)
Outcomes
Primary Outcomes
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).
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).
Secondary Outcomes
- severity of heroin craving(The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).)
- Beck Anxiety inventory (BAI)(The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).)
- Beck Depression Inventory (BDI-II, second edition)(The patients will complete the questionnaire at baseline (first visit), four weeks later (second visit), and eight weeks later (third visit).)
Investigators
Yuan-Yu Chan
Graduate Institute of Integrated Medicine,China Medical University
China Medical University, Taiwan