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Comparison of Haloperidol and Opium Tincture in the control of clinical signs associated with methamphetamine

Protocol summary

Summary
In this experimental study 70 methamphetamine-dependent patients admitted to addiction clinics or psychiatric clinics in the city was selected after completing an informed consent to participate in the study by the patient or guardian him, Randomized to two groups: standard treatment (Haloperidol) and intervention (Opium Tincture) are divided. Inclusion criteria: Methamphetamine dependence (More than 10 times the regular use of methamphetamine or 10 days); Positive Methamphetamine urine test; Age 18-65; Note dependency to other opioid and opium; Exclusion criteria: Other addictive drugs or alcohol or drug use during the study period; Non-compliance with medication orders during the study; There are other mental disorders that require treatment or the risk of suicide; Significant diseases of the Thyroid, Kidney, Liver, Gastrointestinal or Cardiovascular; History of diabetes or Heart attack; In the first and last study completed questionnaires contained demographic information, past history, physical exam and psychological exam. This information contain weight, Appetite, sleep, daily activity, psychotic reaction, anxiety and craving. The paitents deveised two groups (standard treatment and intervention). Standard group give Haloperidol 1mg during 1week, than 1mg/bid during 3 week .Intervention group give Opium tincture 14cc/day during 2week, than is low 1cc every 4 days. All data comparing the efficacy of two drugs became two groups will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080223470N1
Registration date: 2015-09-11, 1394/06/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-11, 1394/06/20
Registrant information
Name
Mohammad Fazli
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
m.fazli@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Haloperidol and Opium Tincture in the control of clinical signs associated with methamphetamine
Public title
The effects of Opium Tincture in the control of clinical signs associated with methamphetamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Dependence on methamphetamine (more than 10 times the regular use of methamphetamine or 10 days); Urine tests positive for methamphetamine; Age 18-65 years; Independence and no use of drugs or other addictive drugs at the time of presentation; Complete the consent form; To track patient; Exclusion criteria: Unwillingness person to continue treatment; Patient self-medication or participate in another study; Other addictive drugs or alcohol or drug use during the study period; Non-compliance with medication orders during the study; Coming out of treatment (imprisonment, death, ...); Any behavior that resulted in dismissal laws rehab clinic patient; There are other mental disorders that require treatment or the risk of suicide; Significant diseases of the Thyroid, Kidney, Liver, Gastrointestinal or Cardiovascular; History of diabetes or Heart attack, Seizures, Glaucoma, Tick, Tardive dyskinesia; Female without adequate contraception pregnancy or lactation; Tincture of opium abusers; A history of allergy to Haloperidol; Simultaneous treatment with antipsychotics or mood stabilizers or CYP 2D6 inhibitors Contains: Amiodarone, Bupropion, Celecoxib, Cimetidine, Chlorpromazine, Clomipramine, Fluoxetine, Haloperidol, Methadone, Moclobemide, Paroxetine, Quinidine, Ritonavir, Sertraline, Terbinafine and Thioridazine; So dangerous side effects of medications or the patient is intolerable.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Sardasht Site
City
Arak
Postal code
Approval date
2014-10-20, 1393/07/28
Ethics committee reference number
93-169-12

Health conditions studied

1

Description of health condition studied
Methamphetamin dependency
ICD-10 code
T43.6
ICD-10 code description
Psychostimulants with abuse potential

Primary outcomes

1

Description
Sleep condition improve
Timepoint
Befor and during and after invetervention
Method of measurement
Beck questionnaire

2

Description
Psychotic reaction
Timepoint
Befor and during and after invetervention
Method of measurement
Beck questionnaire and Psychological exam

3

Description
Craving
Timepoint
Befor and during and after invetervention
Method of measurement
Psychological exam

Secondary outcomes

empty

Intervention groups

1

Description
Standard group give Haloperidol 1mg during 1week, than 1mg/bid during 3 week.
Category
Treatment - Drugs

2

Description
Intervention group give Opium tincture 14cc/day during 2week, than is low 1cc every 4 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Public Free Clinic addiction
Full name of responsible person
Dr.Mohammad jamalian
Street address
Jahantash alley, Shariati st,
City
Arak

2

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr. mohammad fazli
Street address
Valiasr Square
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, University of Medical Sciences
Full name of responsible person
Mehdi shafiee
Street address
Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Dr. mohammad fazli
Position
Medical student
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 4633 2542
Fax
Email
mohammadfazli69@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. mohammad jamalian
Position
Assistant Professor
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 3222 2003
Fax
Email
jamalian_m@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.mohammad fazli
Position
Medical student
Other areas of specialty/work
Street address
City
Arak
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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