Compare Methadone Combined With N-Acetyl-Cysteine (NAC) and Methadone Alone for Opioids Astaining (MNAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047956
Recruitment Status : Unknown
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : January 13, 2010
Last Update Posted : January 14, 2010
Information provided by:
Taichung Veterans General Hospital

Brief Summary:
Evaluation whether higher retention rate is in those of combined methadone with N-Acetyl-Cysteine compared to those with methadone alone during a six-month study.

Condition or disease Intervention/treatment Phase
Opioids Use Drug: Methadone; NAC Drug: Methadone Phase 4

  Hide Detailed Description

Detailed Description:

Material abuse nowadays become a serious public health issue, among these, abusing of opioids is the most serious one. It cause HIV infection rate hiking up, recent years in Taiwan, it impairing people health as well. The successive 2 year methadone substitutive abstaining program makes HIV infection rate remarkable decreasing which proven this public health program is successful in controlling HIV spreading. However, methadone substitutive abstaining program can reduce physically and psychologically dependent with opioids for the opioid abusers, collateral benefit is reducing related criminal behaviors and dangerous contagious behaviors, such as sharing the hyperdermic needle.

On the other hand, using methadone still causes sort of material dependent, for example, part of participants of methadone substitutive abstaining program still keep using heroin, the only change is the amount became lesser, even divert into another illegal drugs, compare before participating this program. In the other word, methadone substitutive abstaining program alleviate the dependence of drug abuser for the drug, but can not cure it once for all. In the pass, some study use methadone and other medicine to eradicate this dependence, still there is no effective way to approach it, it still has long way to go. Previous studies found N-acetylcysteine (NAC), a slimy solvent ingredient in human body, by means of extra-cellular glutamate exchange mechanism, not only maintain glutamate concentration inside the raphe, also alleviate motivation and behavior of addictive patient. From previous reports, N-acetylcysteine could be the silver bullet for the opiods addiction patients. The clinical use of N-acetylcysteine is well established for safety as well as tolerance. N-acetylcysteine is an acetyl-derivative of a human essential amino acid; molecular weight is 163.2, a white crystal chemical. N-acetylcysteine has been used in clinical for years, types are intravenous injection, oral and spray, most of it was used for respiratory related disease, a phlegm reducer, such as chronic obstructive pulmonary disease and cystic fibrosis; besides, N-acetylcysteine can combine with toxic metabolite, acetaminophen, prevent lever necrosis of acetaminophen intoxication, therefore, is an antidote of acetaminophen intoxication. Other than FAD approved for clinical using, N-acetylcysteine seems has other clinical benefits such as illness of kidney from the developer, and can promote functions of central nerve system. N-acetylcysteine also considered as improving cognition amnesia and schizophrenia. Besides, oral N-acetylcysteine usually regards as helping health; it sells in grocery, it also accepted by public as diet supplement. According long term study of oral N-acetylcysteine for patients of chronic obstructive pulmonary disease, only has some minor side-effects, mostly uncomfortable in intestines and stomach, for example, nausea, vomiting and diarrhea. As an antidote of N-acetylcysteine, some cases reported which caused hypertension, chest distress, rectum breeding, respiratory distress, headache, fatigue, fever and rash; those symptoms are intoxication of acetaminophen, it is hard to judge the side-effects came from which one. The side-effects of intravenous N-acetylcysteine include vomiting and diarrhea; some cases indicated 45 (8%) out of 529 patients of acetaminophen intoxication showed allergic reactions, most are skin hypersensitive reaction, such as rash, itch, 18 showed whole-body allergy include, bronchospasm, angioedema and vomiting etc. Those allergies can be alleviated by antihistamine, steroids and adrenalin. Other researchers found patients have 3 fold systemic allergy of asthma history than no history. In general, medicine allergic history will not increase danger of allergic reaction. One case report showed a 2 year old girl, a acetaminophen intoxication patient, caused a serious epilepsy when treated with intravenous injection. Conclude that oral and intravenous of N-acetylcysteine are safe in clinical use, few cases could cause serious side-effects (especially for intravenous type of N-acetylcysteine), and it needs to be careful. From the result of animal test in 2008, gave N-acetylcysteine daily suppressed experimental animal addiction behavior, even still held valid 40 days after stopped injection. Another animal test using male Sprague-Dawley had similar results. According previous results, N-acetylcysteine was used for alleviation of addiction behavior proven in certain effectiveness, if combine with methadone substitutive abstaining program, should increase successful rate. In this study, double-blind prospective study will be used, in methadone substitutive abstaining program to compare N-acetylcysteine is be used or not. This experiment expects methadone come alone with N-acetylcysteine in opioid abstaining will be better results than control group of methadone alone in 6 month period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation Whether Higher Retention Rate is in Those of Combined Methadone With N-Acetyl-Cysteine Compared to Those With Methadone Alone During a Six-month Study
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: MethNAC
Methadone and N-acetylcysteine for opioids abstaining
Drug: Methadone; NAC
Methadone NAC
Active Comparator: Methadone
Methadone alone
Drug: Methadone

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age between 20-65 years old, all genders.
  2. Psychiatry doctor diagnosed who met DSMIV-TR criteria opioid addiction or opioid abusing.
  3. Participants need to understand procedures and assays of this experiment.
  4. Participants are willing to accept methadone substitutive abstaining program.
  5. Participants are willing to provide small amount of blood for testing.
  6. Participants are voluntarily to join interview(s), approximately 30-45min.

Exclusion Criteria:

  1. Participants have respiratory distress or other respiratory system illnesses.
  2. Participants have serious illness and possible die within 1 year or intensive care needed within 6 month.
  3. Participants have been diagnosed cardio-vascular disease recently.
  4. Participants have allergy to N-acetylcysteine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047956

Contact: Tsuo-Hung Lan, MD., PhD. 04-23592525 ext 3460
Contact: Chia-Fen Chang, MD. 04-23592525 ext 3404

Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Contact: Tsuo-Hung Lan, MD., PhD.    886-4-23592525 ext 3460   
Contact: Chia-Fen Chang, MD.    886-4-23592525 ext 3404      
Sponsors and Collaborators
Taichung Veterans General Hospital
Study Director: Tsuo-Hung Lan, MD., PhD. Taichung Veterans General Hospital

Responsible Party: IRB TCVGH, Taichung Veterans General Hospital Identifier: NCT01047956     History of Changes
Other Study ID Numbers: C09075
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Taichung Veterans General Hospital:

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Antiviral Agents
Anti-Infective Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents