Compare Methadone Combined With N-Acetyl-Cysteine (NAC) and Methadone Alone for Opioids Astaining
Information source: Taichung Veterans General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioids Use
Intervention: Methadone; NAC (Drug); Methadone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Taichung Veterans General Hospital Official(s) and/or principal investigator(s): Tsuo-Hung Lan, MD., PhD., Study Director, Affiliation: Taichung Veterans General Hospital
Overall contact: Tsuo-Hung Lan, MD., PhD., Phone: 04-23592525, Ext: 3460
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Tsuo-Hung Lan, MD., PhD., Phone: 04-23592525, Ext: 3460
Taichung Veterans General Hospital, Taichung City 40705, Taiwan; Recruiting Tsuo-Hung Lan, MD., PhD., Phone: 886-4-23592525, Ext: 3460, Email: tosafish@hotmail.com Chia-Fen Chang, MD., Phone: 886-4-23592525, Ext: 3404
Additional Information
Starting date: June 2009
Last updated: January 13, 2010
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