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

NCT01913418 | Completed Phase 2 DMC

• 1 other identifier: NSC 102-2320-B-039-024-
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Dependence

Keywords

Traditional Chinese Medicine; Suan-Zao-Ren Tang; Methadone; Opiate dependence; Sleep

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (3)

• 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).

Study Arms (2)

Suan-Zao-Ren Tang

ACTIVE COMPARATOR

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.

Drug: Suan-Zao-Ren Tang

Suan-Zao-Ren Tang placebo

PLACEBO COMPARATOR

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

Drug: Suan-Zao-Ren Tang placebo

Interventions

Suan-Zao-Ren Tang DRUG

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

Suan-Zao-Ren Tang placebo DRUG

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

Suan-Zao-Ren Tang placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, Taiwan: lead

Study Sites (1)

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

Taoyuan District, 325, Taiwan

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Institute of Integrated Medicine,China Medical University

Study Record Dates

• First Submitted: July 28, 2013
• First Posted: August 1, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

TW (1)