The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts

Opiate Dependence Clinical Trial

Official title:

The Clinical Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512433
• Other study ID #: NSC 100-2320-B-039-029-MY2
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: March 21, 2013
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: China Medical University, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

Description:

Methadone maintenance therapy for the treatment of heroin addicts for more than 40 years , and there are many studies confirm its effectiveness, such as reduced heroin addiction, reduced high-risk needle use, reduced criminal activity. But methadone also had side effects such as drowsiness, constipation, insomnia, nausea, vomiting, sweating and respiratory depression.Then the long-term heroin addicts may irregular to take methadone, which increase the risk of reuse heroin or other drugs. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to investigate the efficacy of acupuncture therapy combined with standard methadone maintenance therapy to the heroin addicts.

The study will be consisted of 60 heroin addicts and the inclusion criteria were: (1) age more then 20 years; (2) fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence and had been received methadone maintenance treatment for more then one month. Subjects were excluded if they: (1) concurrent treatment with antidepressant or neuroleptic medication; (2) had taking acupuncture treatment in past 30 days; (3) had severe adverse effects or events history from receiving acupuncture treatment; (4) had any serious physical illness; (5) had a significant risk of suicide; (6) ear infection; (7) were pregnant or or a woman plan to pregnant; (8) had bleeding disorders or were taking anticoagulant drugs; (9) Human Immunodeficiency Virus (HIV) positive; (10) had epilepsy, cerebral vascular disease and brain injured history.The study used a randomized, placebo-controlled study design. Patients were randomly assigned to receive methadone with verum acupuncture condition (n = 30), methadone with sham acupuncture condition (n = 30). Treatments were offered 2 times weekly for 4 weeks. Weekly measures of methadone dosage and using the visual analog scale (VAS) to assess the craving severity for 4 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to provide an assessment of quality of life and sleep quality over the previous 4 weeks.

The study hypothesis was acupuncture had clinical efficacy upon craving severity, life quality, reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for opiate dependence and had been received methadone maintenance treatment for more then one month.

Exclusion Criteria:

• concurrent treatment with antidepressant or neuroleptic medication

• had taking acupuncture treatment in past 30 days

• had severe adverse effects or events history from receiving acupuncture treatment

• had any serious physical illness

• had a significant risk of suicide

• ear infection

• were pregnant or or a woman plan to pregnant

• had bleeding disorders or were taking anticoagulant drugs

• Human Immunodeficiency Virus (HIV) positive

• had epilepsy, cerebral vascular disease and brain injured history.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

Procedure:
• Ture acupuncture
Ture acupuncture included shenmen point in the ear cartilage ridge area without electrical stimulation and Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation. The frequency of stimulation alternated between 20 and 100 Hz (dense and disperse, DD) at automatic 2-second intervals. The intensities of the stimulations were increased in 1 mA increments to maximal tolerable intensity.
• Sham acupuncture
The needles on the bilateral Hegu (LI 4) and Zusanli (ST 36) were then connected to the electro-acupuncture machine with zero frequencies and amplitude."DeQi"was avoided during needling.

Locations

Country	Name	City	State
Taiwan	Department of psychiatry, Armed Forces Tao-Yuan General Hospital, No.168 Zhong-Xing Road, Taoyuan, Taiwan.	Longtan	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid craving	opioid craving scores on the Visual Analog Scale	four weeks	No
Secondary	sleep quality	sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)	four weeks	No
Secondary	life quality	life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)	four weeks	No