Nowadays methamphetamine is one of the most prevalent drugs of abuse in Iran. It can cause different medical such as cardiovascular side effects as well as psychiatric side effects like psychosis. Currently there is no approved drug for reducing craving for methamphetamine. N-acetyl cysteine is one of drugs that is suggested for this purpose according to previous trails on reduction of craving in methamphetamine and cocaine. This study uses a randomized, double-blind, placebo-controlled, cross over clinical trial design. Subjects will be treatment-seeking males and females who meet DSM-IV criteria for methamphetamine dependency, which will be selected from patients, who refer to Noor Hospital psychiatric emergency, psychiatric clinic or drug dependency treatment center. This will be done approximately from May, 2012 until May, 2013. After screening, eligible subjects were randomly assigned to NAC or placebo. For each group there will be a six weeks treatment program and then the placebo and NAC group will be exchanged. In NAC group drug will be started at 1200 mg/day and will be raised to 2400 mg/day after 2 weeks, and to 3600 mg/day after 4 weeks, and will be continued until week 6.The craving will be assessed with Cocaine Craving Questionnaire-Brief (CCQ-Brief) at screening and every 2 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205317841N2
Registration date:2012-07-13, 1391/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-13, 1391/04/23
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Psychiatric group, Isfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2457
Email address
sharbafchi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Behavioral Sciences Research Center
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of N-acetyl cysteine (NAC) and placebo in craving reduction in methamphetamine dependent subjects
Public title
Assessment of NAC efficacy for reducing of craving in patients with methamphetamine dependency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) men and women aged 18–65 years old; 2) informed acceptance to comply with study procedures. Exclusion criteria: 1) sever medical illness that would impair the ability to participate safely in the study; 2) a current neurological or axis I psychiatric disorders not due to substance abuse (e.g., schizophrenia, dementia) that would impair ability to participate safely in the study; 3) current pregnancy or nursing in women; 4) current serious suicidal intention or plan; 5) more than 3 times elevation of AST and ALT at screening; 6) past medical history of asthma or seizures; 7) Subjects who had recently used medications (<14 days) felt to be hazardous if taken with NAC (e.g. carbamazepine, nitroglycerin); and 8) subjects who met DSM-IV criteria for opiates dependence. Also in following conditions the patient will be out of study: 1) incidence of seizure or sever medical illness that would impair ability to participate safely in the study; 2) non compliance or not willing for continuing the study; 3) sever and unbearable drug side effect even after reducing the dose.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjarib Street
City
Isfahan
Postal code
Approval date
2012-05-30, 1391/03/10
Ethics committee reference number
8/3834/د
Health conditions studied
1
Description of health condition studied
Methamphetamine Dependency
ICD-10 code
F15.2
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Methamphetamine Craving
Timepoint
At screening and every 2 weeks up to 6 weeks
Method of measurement
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: drug will be started at 1200 mg/day and will be raised to 2400 mg/day after 2 weeks, and to 3600 mg/day after 4 weeks, and will be continued until week 6.
Category
Treatment - Drugs
2
Description
Control: Placebo with numbers equal to main drug in 2 weeks intervals.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Drug Treatment Center, Emergency and Clinic of Noor Hospital
Full name of responsible person
Mohammad Reza Sharbafchi zade
Street address
Noor Hospital, Ostandari street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Behavioral Sciences Research Center
Full name of responsible person
Dr Abas Atari
Street address
Noor Hospital, Ostandari Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Behavioral Sciences Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Psychiatry, Isfahan University of Medical Sciences